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FDA 510(k)

MENISCAL REPAIR DEVICE

K-Number: K981692 · 1998-07-27

ApplicantLinvatec Corp.
Decision Date1998-07-27
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENISCAL REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-07-27 under 510(k) number K981692. 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 MENISCAL REPAIR DEVICE?

MENISCAL REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 1998-07-27. The listed applicant is Linvatec Corp.. The 510(k) number is K981692.

When did MENISCAL REPAIR DEVICE receive FDA 510(k) clearance?

MENISCAL REPAIR DEVICE received FDA 510(k) clearance on 1998-07-27, under 510(k) number K981692.

Who is the listed applicant for MENISCAL REPAIR DEVICE?

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 MENISCAL REPAIR DEVICE?

The FDA product code for MENISCAL REPAIR DEVICE 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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