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FDA 510(k)

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR

K-Number: K100159 · 2010-04-19

ApplicantSmith & Nephew Inc., Endoscopy Div.
Decision Date2010-04-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2010-04-19 under 510(k) number K100159. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR?

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2010-04-19. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K100159.

When did SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR receive FDA 510(k) clearance?

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR received FDA 510(k) clearance on 2010-04-19, under 510(k) number K100159.

Who is the listed applicant for SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR?

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

What is the FDA product code for SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR?

The FDA product code for SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR is MBI.

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Other records listing Smith & Nephew Inc., Endoscopy Div. 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.

K242631REGENETEN™ Bioinductive ImplantK111843ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEMK102544SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAYK092551SMITH & NEPHEW INSTRUMENT TRAYSK093943BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MMK093897SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR

View all 10 devices →

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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