DePuy Synthes Trauma Orthopedic Nail Implants
K-Number: K182783 · 2018-12-26
ApplicantDePuy Synthes
Decision Date2018-12-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DePuy Synthes Trauma Orthopedic Nail Implants is a medical device manufactured by DePuy Synthes. It received FDA 510(k) clearance on 2018-12-26 under approval number K182783. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DePuy Synthes Trauma Orthopedic Nail Implants?
DePuy Synthes Trauma Orthopedic Nail Implants is a medical device that received FDA 510(k) clearance on 2018-12-26. It is manufactured by DePuy Synthes. The 510(k) number is K182783.
When was DePuy Synthes Trauma Orthopedic Nail Implants approved by the FDA?
DePuy Synthes Trauma Orthopedic Nail Implants received FDA 510(k) clearance on 2018-12-26, under approval number K182783.
What company makes DePuy Synthes Trauma Orthopedic Nail Implants?
DePuy Synthes Trauma Orthopedic Nail Implants is manufactured by DePuy Synthes.
What is the FDA product code for DePuy Synthes Trauma Orthopedic Nail Implants?
The FDA product code for DePuy Synthes Trauma Orthopedic Nail Implants is HRS.
Related Clinical Trials
NCT05147363
Shockwave: Disruption for A Better Fit
WITHDRAWN
NCT07336277
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
NOT_YET_RECRUITING
NCT04103502
In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA
WITHDRAWN
NCT07563803
The restor3d Outcomes Registry
NOT_YET_RECRUITING
NCT07544264
Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component
NOT_YET_RECRUITING
NCT07485829
Zimmer Biomet-RibFix Titan
RECRUITING
Related PubMed Literature
PMID: 42014629
Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction.
3D printing in medicine (2026)
PMID: 41388920
Balancing Innovation and the Safe Introduction of Orthopedic Arthroplasty Implants to Market: The Ever-Evolving Regulatory Environment in Australia.
Journal of orthopaedic research : official publication of the Orthopaedic Research Society (2026)
PMID: 40528079
The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey.
Therapeutic innovation & regulatory science (2025)
Other Devices by DePuy Synthes
K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
K163046DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
K172872DePuy Synthes Femoral Neck System
K190750DePuy Synthes Plates and Screws Portfolio
K190409MatrixRIB Fixation System
K203414DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Related Devices (Code: HRS)
K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.
K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation
K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation
K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.