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FDA 510(k)

BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK

K-Number: K955003 · 1996-01-31

ApplicantBioscience, Inc.
Decision Date1996-01-31
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK is the device name listed in this FDA 510(k) record. The listed applicant is Bioscience, Inc.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K955003. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK?

BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Bioscience, Inc.. The 510(k) number is K955003.

When did BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK receive FDA 510(k) clearance?

BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK received FDA 510(k) clearance on 1996-01-31, under 510(k) number K955003.

Who is the listed applicant for BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK?

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 SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK?

The FDA product code for BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK 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.

K955768BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEMK952471BIOFIX 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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