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FDA 510(k)

BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM

K-Number: K955768 · 1996-03-04

ApplicantBioscience, Inc.
Decision Date1996-03-04
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioscience, Inc.. It received FDA 510(k) clearance on 1996-03-04 under 510(k) number K955768. 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 BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM?

BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-04. The listed applicant is Bioscience, Inc.. The 510(k) number is K955768.

When did BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM receive FDA 510(k) clearance?

BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM received FDA 510(k) clearance on 1996-03-04, under 510(k) number K955768.

Who is the listed applicant for BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM?

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

What is the FDA product code for BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM?

The FDA product code for BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM is MAI.

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Other records listing Bioscience, Inc. 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.

K955003BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACKK952471BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION RODK925098BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

Related Devices (Code: MAI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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