Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TFCC FAST-FIX KIT

K-Number: K132079 · 2013-12-05

ApplicantSmith & Nephew, Inc.
Decision Date2013-12-05
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TFCC FAST-FIX KIT 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 2013-12-05 under 510(k) number K132079. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TFCC FAST-FIX KIT?

TFCC FAST-FIX KIT is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K132079.

When did TFCC FAST-FIX KIT receive FDA 510(k) clearance?

TFCC FAST-FIX KIT received FDA 510(k) clearance on 2013-12-05, under 510(k) number K132079.

Who is the listed applicant for TFCC FAST-FIX KIT?

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 TFCC FAST-FIX KIT?

The FDA product code for TFCC FAST-FIX KIT is GAT.

Other records listing Smith & Nephew, Inc. 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.

K261462LANDMARK Total Knee SystemK261968Q-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 GlenoidsK252416AETOS Shoulder System Meta Humeral Prosthesis Size 0K252129AETOS Shoulder System Stemless Humeral ProsthesisK251627BIORAPTOR 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)

View all 509 devices →

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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.

↑