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FDA 510(k)

BIO-ANCHOR

K-Number: K955486 · 1996-02-29

ApplicantLinvatec Corp.
Decision Date1996-02-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIO-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 1996-02-29 under 510(k) number K955486. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIO-ANCHOR?

BIO-ANCHOR is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Linvatec Corp.. The 510(k) number is K955486.

When did BIO-ANCHOR receive FDA 510(k) clearance?

BIO-ANCHOR received FDA 510(k) clearance on 1996-02-29, under 510(k) number K955486.

Who is the listed applicant for BIO-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 BIO-ANCHOR?

The FDA product code for BIO-ANCHOR is MAI.

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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: MAI)

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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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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