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FDA 510(k)

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm

K-Number: K201336 · 2020-09-03

ApplicantSynthes (USA) Products, LLC
Decision Date2020-09-03
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-09-03 under approval number K201336. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm?

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K201336.

When was DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm approved by the FDA?

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm received FDA 510(k) clearance on 2020-09-03, under approval number K201336.

What company makes DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm?

DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm?

The FDA product code for DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm is JDS.

Related Clinical Trials

NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

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Related Devices (Code: JDS)

K192003Auxein Nailing SystemAuxein Medical Private Limited K193533WIN Flexible Nail SystemBiomet, Inc. K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.

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.

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