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FDA 510(k)

PRELOADED SOFT TISSUE ANCHOR

K-Number: K953954 · 1996-02-20

ApplicantLinvatec Corp.
Decision Date1996-02-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PRELOADED SOFT TISSUE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1996-02-20 under 510(k) number K953954. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PRELOADED SOFT TISSUE ANCHOR?

PRELOADED SOFT TISSUE ANCHOR is a medical device that received FDA 510(k) clearance on 1996-02-20. The listed applicant is Linvatec Corp.. The 510(k) number is K953954.

When did PRELOADED SOFT TISSUE ANCHOR receive FDA 510(k) clearance?

PRELOADED SOFT TISSUE ANCHOR received FDA 510(k) clearance on 1996-02-20, under 510(k) number K953954.

Who is the listed applicant for PRELOADED SOFT TISSUE ANCHOR?

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 PRELOADED SOFT TISSUE ANCHOR?

The FDA product code for PRELOADED SOFT TISSUE ANCHOR 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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