FDA 510(k)

TRIGEN META-NAIL Nail System

K-Number: K230761 · 2023-06-14

Decision Date2023-06-14

Product CodeJDS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRIGEN META-NAIL 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 2023-06-14 under 510(k) number K230761. 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 Nail System?

TRIGEN META-NAIL Nail System is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K230761.

When did TRIGEN META-NAIL Nail System receive FDA 510(k) clearance?

TRIGEN META-NAIL Nail System received FDA 510(k) clearance on 2023-06-14, under 510(k) number K230761.

Who is the listed applicant for TRIGEN META-NAIL 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 META-NAIL Nail System?

The FDA product code for TRIGEN META-NAIL Nail System is JDS.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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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.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

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.