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FDA 510(k)

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER

K-Number: K050227 · 2005-03-02

ApplicantLinvatec Corp.
Decision Date2005-03-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2005-03-02 under 510(k) number K050227. 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 THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER?

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER is a medical device that received FDA 510(k) clearance on 2005-03-02. The listed applicant is Linvatec Corp.. The 510(k) number is K050227.

When did THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER receive FDA 510(k) clearance?

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER received FDA 510(k) clearance on 2005-03-02, under 510(k) number K050227.

Who is the listed applicant for THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER?

The FDA product code for THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER is MBI.

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Other records listing Linvatec Corp. 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

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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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