Rod, Fixation, Intramedullary And Accessories
FDA product code HSB · 490 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3020
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-11-11 – 2026-09-24
HSB
2019-09-03
HSB
2019-07-18
AOS ES Retrograde Femoral Nail
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HSB
2019-07-05
Zimmer Guide Wire Devices
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HSB
2019-06-11
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
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HSB
2019-04-11
Syntec Femoral Nail System
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HSB
2019-02-05
PRECICE® BONE TRANSPORT™ System
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HSB
2019-01-16
Estremo Citieffe Nailing System
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HSB
2019-01-14
Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
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HSB
2018-12-14
Affixus Hip Fracture Nail
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HSB
2018-12-14
Affixus Natural Nail System Humeral Nail
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HSB
2018-11-02
Panta 2 Arthrodesis Nail System
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HSB
2018-10-17
OsteoBridge™ IDSF System
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HSB
2018-10-12
X-BOLT Hip Fracture Fixation System
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HSB
2018-08-24
Double Medical Femoral Nail System
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HSB
2018-07-27
OIC Intramedullary Nail System
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HSB
2018-07-26
Arthrex FibuLock Nail
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HSB
2018-07-17
Apex Femoral Nailing System
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HSB
2018-06-06
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
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HSB
2018-05-10
OrthoPediatrics PediNail Intramedullary Platform
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HSB
2018-04-23
Agile Nail
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HSB
2018-04-03
PRECICE STRYDE System
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HSB
2018-03-15
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
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HSB
2018-02-22
Talon DistalFix Humeral Nail
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HSB
2018-01-16
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
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HSB
2018-01-12
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
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HSB
2017-12-29
AUTOBAHN Nailing System
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HSB
2017-12-28
Piccolo Composite Nailing System
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HSB
2017-12-20
Apex Tibial Nailing System
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HSB
2017-12-07
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
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HSB
2017-12-01
PRECICE System
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HSB
2017-11-14
DePuy Synthes Femoral Recon Nail System
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HSB
2017-11-02
DynaNail TTC Fusion System
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HSB
2017-10-30
Flex-Thread Fibula Pin System
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HSB
2017-10-13
NOVOS-NAIL Limb Lengthening System (LLS)
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HSB
2017-09-25
PRECICE System
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HSB
2017-09-14
Shotel Ankle Arthrodesis Nail System
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HSB
2017-08-24
PRECICE UNYTE System
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HSB
2017-08-10
Zimmer Natural Nail System
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HSB
2017-07-20
SIGN IM Nail
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HSB
2017-06-09
PRECICE Intramedullary Limb Lengthening System
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HSB
2017-06-08
SYNTEC HUMERAL NAIL SYSTEM
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HSB
2017-04-06
PRECICE UNYTE CoCr System
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HSB
2017-03-20
Flex-Thread Clavicle Pin System
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HSB
2017-03-07
PRECICE Intramedullary Limb Lengthening System
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HSB
2017-02-24
Sonoma Fifth Metatarsal Repair System
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HSB
2017-01-26
FITBONE TAA
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HSB
2017-01-24
AOS Small Bone Nailing System
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HSB
2017-01-24
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
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HSB
2016-11-23
TRIGEN Low Profile Bone Screws
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HSB
2016-11-23
GAP ENDO-EXO MEDULLARY SYSTEM
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HSB
2016-11-07
Renovo Life Small Bone IM Nail System
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HSB
2016-09-26
DePuy Synthes TFNA Augmentation System
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HSB
2016-04-04
PRECICE Intramedullary Limb Lengthening System
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HSB
2016-03-31
PRECICE Trauma Nail System
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HSB
2016-03-10
Sonoma Fibula Repair System
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HSB
2016-01-06
Piccolo Composite® Nailing System
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HSB
2013-12-31
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
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HSB
2013-12-20
IDEAL
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HSB
2013-12-09
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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HSB
2013-12-05
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
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HSB
2013-10-11
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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HSB
2013-10-10
T2 TIBIAL NAILING SYSTEM
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HSB
2013-10-03
PICCOLO COMPOSITE NAILING SYSTEM
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HSB
2013-09-17
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
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HSB
2013-09-10
RETROGRADE FEMORAL NAIL
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HSB
2013-07-15
611 ANKLE FUSION NAIL
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HSB
2013-06-25
EBA2 FEMORAL NAILING SYSTEM
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HSB
2013-06-14
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
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HSB
2013-05-24
ANTEGRADE FEMORAL NAIL
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HSB
2013-05-03
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
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HSB
2013-04-16
SIGN PEDIATRIC FIN NAIL
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HSB
2013-03-28
12MM AND 13MM TIBIAL NAILS
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HSB
2013-03-25
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
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HSB
2013-01-23
GAMMA3 AND T2 RECON TARGETING DEVICES
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HSB
2012-10-24
INTRAMEDULLARY NAIL SYSTEM
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HSB
2012-10-19
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
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HSB
2012-10-19
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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HSB
2012-10-02
AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW
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HSB
2012-09-14
OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
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HSB
2012-08-10
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
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HSB
2012-07-06
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
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HSB
2012-05-21
DYNA LOCKING ANKLE NAIL
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HSB
2012-05-03
FORCE MEDICAL IM NAIL SYSTEM
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HSB
2012-05-02
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
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HSB
2012-04-02
ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )
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HSB
2012-03-28
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
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HSB
2012-03-15
CITIEFFE TITANIUM NAILING SYSTEM
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HSB
2012-02-29
DYNANAIL ANKLE ARTHRODESIS NAIL
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HSB
2012-02-15
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
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HSB
2012-02-08
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
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HSB
2012-01-26
GAP ENDO-EXO MEDULLARY SYSTEM
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HSB
2011-12-09
OSLEOBRIDGE IDSF SPACER CONECTOR
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HSB
2011-11-28
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
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HSB
2011-11-14
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
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HSB
2011-08-22
TALON DISTALFIX PROXIMAL FEMORAL NAIL
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HSB
2011-08-19
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
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HSB
2011-08-08
T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
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HSB
2011-08-03
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
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HSB
2011-07-12
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
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HSB
2011-07-01
TRIGEN LOW PROFILE BONE SCREW
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