FDA 510(k)

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Numéro K : K240061 · 2024-09-20

Date de décision2024-09-20

Code produitJDS

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System 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 2024-09-20 under 510(k) number K240061. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240061.

When did TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System receive FDA 510(k) clearance?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240061.

Who is the listed applicant for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

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 MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

The FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is JDS.

Essais cliniques associés

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Autres dossiers indiquant Smith & Nephew, Inc. en tant que demandeur

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Dispositifs connexes (Code : JDS)

K243608TRIGEN Stable Lock Nut & WasherSmith & 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 K192003Auxein Nailing SystemAuxein Medical Private Limited

Source officielle

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