FDA 510(k)

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS

K-Number: K061019 · 2006-06-06

Decision Date2006-06-06

Product CodeJDS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K061019. 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 TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS?

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K061019.

When did TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS receive FDA 510(k) clearance?

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS received FDA 510(k) clearance on 2006-06-06, under 510(k) number K061019.

Who is the listed applicant for TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS?

The FDA product code for TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS is JDS.

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Related Devices (Code: JDS)

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.