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FDA 510(k)

CONMED LINVATEC INTERCEPT IMPLANT

K-Number: K092998 · 2009-12-23

ApplicantLinvatec Corp.
Decision Date2009-12-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONMED LINVATEC INTERCEPT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2009-12-23 under 510(k) number K092998. 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 CONMED LINVATEC INTERCEPT IMPLANT?

CONMED LINVATEC INTERCEPT IMPLANT is a medical device that received FDA 510(k) clearance on 2009-12-23. The listed applicant is Linvatec Corp.. The 510(k) number is K092998.

When did CONMED LINVATEC INTERCEPT IMPLANT receive FDA 510(k) clearance?

CONMED LINVATEC INTERCEPT IMPLANT received FDA 510(k) clearance on 2009-12-23, under 510(k) number K092998.

Who is the listed applicant for CONMED LINVATEC INTERCEPT IMPLANT?

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 CONMED LINVATEC INTERCEPT IMPLANT?

The FDA product code for CONMED LINVATEC INTERCEPT IMPLANT 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.

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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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