Plate, Fixation, Bone
FDA product code HRS · 1194 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3030
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-16 – 2026-09-23
HRS
2024-12-23
HRS
2024-12-20
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
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HRS
2024-12-11
SternalPlate Expansion
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HRS
2024-12-05
TDM Plate and Screw System
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HRS
2024-11-26
TriMed Posterior Malleolus Fixation System
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HRS
2024-11-26
HyperFlex™ Bunion Correction System
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HRS
2024-11-21
GMReis Ankle Plating System
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HRS
2024-11-21
Versalock Mini and Micro Plating System
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HRS
2024-11-14
Tandry Q-Locking Plate System
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HRS
2024-11-14
Proximal Humerus Fixation System
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HRS
2024-11-14
Arthrex Elbow Fracture Plating System
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HRS
2024-11-01
Osteotomy Truss System (OTS)
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HRS
2024-10-31
Bonebridge Osteosynthesis Plating System
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HRS
2024-10-23
OIC Small / Mini Fragment Plate System
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HRS
2024-10-21
Arthrex VAL and VAL KreuLock™ Compression Screw System
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HRS
2024-10-09
Clavicle and Scapula System
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HRS
2024-10-06
Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
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HRS
2024-10-04
BPS Wrist Fracture System
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HRS
2024-09-26
Protean Fragment Plating System
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HRS
2024-09-19
Pectus Blu Support Bar System
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HRS
2024-09-17
TriMed Bridge Plates
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HRS
2024-09-05
Fine Osteotomy™
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HRS
2024-09-03
EVOS Patella Plates
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HRS
2024-08-28
REDEMPTION Charcot Plating System
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HRS
2024-08-23
SITTER 3.5mm Versatile System
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HRS
2024-08-19
RibFix Titan™ Fixation System
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HRS
2024-08-15
NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate
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HRS
2024-08-13
CoLink NeoFuse MIS Plating System (see attached parts list)
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HRS
2024-08-01
Freefix Forearm Plating System
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HRS
2024-07-30
Activmotion S
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HRS
2024-07-26
VOLT™ Proximal Humerus 3.5 Plating System
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HRS
2024-07-23
Gaudi Proximal Humerus Plate
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HRS
2024-07-12
KLS Martin Orthopedic Implants - MR Conditional
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HRS
2024-06-26
Forma Medical Optimal Plating System
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HRS
2024-06-26
Versalock Rib and Sternum Plates System
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HRS
2024-06-20
APTUS Elbow Dorsal Olecranon Plates
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HRS
2024-06-11
SIGNEX
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HRS
2024-06-05
Baby Gorilla/Gorilla Plating System; Monster Screw System
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HRS
2024-05-31
Tyber Medical Anatomical Plating System
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HRS
2024-05-24
NeoSpan® Compression Implant System
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HRS
2024-05-09
DePuy Synthes MatrixSTERNUM Fixation System
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HRS
2024-04-26
XLO Brand of Locking Distal Humerus Plating System
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HRS
2024-04-22
Acumed Wrist Plating System
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HRS
2024-04-19
APTUS Foot System 2.8-3.5
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HRS
2024-04-17
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
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HRS
2024-04-12
Fine Osteotomy™
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HRS
2024-04-05
TDM Large Bone Plate and Screw System
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HRS
2024-03-25
VariAx 2 Distal Radius System
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HRS
2024-03-21
APTUS Hand Scaphoid Plates
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HRS
2024-03-21
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
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HRS
2024-02-22
Treace Medical Systems (TMC) Plating System
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HRS
2024-01-19
HKT Anatomical Locking Trauma System
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HRS
2024-01-18
Medline UNITE Ancillary Foot Recon Plating System
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HRS
2024-01-12
Quick - Radius Disposable Set
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HRS
2023-12-21
Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
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HRS
2023-12-21
SkyOPS™ Orthopedic Plate System
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HRS
2023-12-20
TM Plating System
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HRS
2023-12-15
Internal Locking Plate and Screw Fixation System
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HRS
2023-12-14
ARIX Ankle Distal Tibia System
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HRS
2023-12-13
Anatomical Plating System (various)
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HRS
2023-12-08
Valkyrie Thoracic Fixation System
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HRS
2023-12-04
Tyber Medical Distal Radius Plating System
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HRS
2023-09-29
TriLEAP Plating System
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HRS
2023-09-25
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
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HRS
2023-09-01
TriMed Clavicle Fixation System
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HRS
2023-09-01
KITE Distal Fibula Kit
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HRS
2023-08-28
Distal Elbow Plating System
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HRS
2023-08-24
APS Metal Plate & Screw System
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HRS
2023-08-18
Sterile Products of the APTUS System
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HRS
2023-08-18
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
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HRS
2023-08-18
Pangea Utility Plating System, Pangea Platform
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HRS
2023-08-17
Tandry Locking Plate System
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HRS
2023-07-19
TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
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HRS
2023-07-17
ARIX Ankle System
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HRS
2023-06-02
APTUS® 3.5 TriLock Straight Plates
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HRS
2023-05-30
Smith & Nephew ACCORD™ Cable System
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HRS
2023-05-25
KLS Martin LINOS Wrist System
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HRS
2023-05-03
ARIX Humerus System
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HRS
2023-04-27
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
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HRS
2023-04-25
ALPHALOK Plating System
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HRS
2023-04-07
PRO Plating System, Stryker Trauma Pelvic Set (Matta)
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HRS
2023-03-30
Medartis APTUS® Ulna Plates
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HRS
2023-03-30
MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System
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HRS
2023-03-29
WishBone Medical Plate and Screw System
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HRS
2023-03-29
KLS Martin Level One Rib Fixation System
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HRS
2023-03-28
KLS Martin Pure Pectus System
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HRS
2023-03-17
LOQTEQ® VA Elbow Plates 2.7/3.5 System
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HRS
2023-03-07
Tyber Medical Anatomical Plating System
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HRS
2023-01-27
Tibia and Fibula System
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HRS
2023-01-25
Medline UNITE® Ankle Fusion Plating System
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HRS
2023-01-25
Advanced Bone Plate
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HRS
2023-01-21
OIC Variable Angle Small Fragment Locking Plate System
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HRS
2023-01-18
Anatomic Bone Plate
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HRS
2023-01-05
Treace Medical Concepts (TMC) Plating System
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HRS
2022-12-21
TriMed Wrist Fixation System 3
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HRS
2022-11-22
ARIX Rib System
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HRS
2022-11-15
ALPHALOK Plating System
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HRS
2022-11-04
Humerus & Ulna System
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HRS
2022-10-27
HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
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HRS
2022-10-18
EVOS Wrist Spanning Plate
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