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FDA 510(k)

UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL

K-Number: K914453 · 1992-02-18

ApplicantSynthes (Usa)
Decision Date1992-02-18
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K914453. 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 UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL?

UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Synthes (Usa). The 510(k) number is K914453.

When did UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL receive FDA 510(k) clearance?

UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL received FDA 510(k) clearance on 1992-02-18, under 510(k) number K914453.

Who is the listed applicant for UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL?

The FDA product code for UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL is JDS.

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Other records listing Synthes (Usa) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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Related Devices (Code: JDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243608TRIGEN Stable Lock Nut & WasherSmith & 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.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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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