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FDA 510(k)

BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD

K-Number: K952471 · 1995-08-07

ApplicantBioscience, Inc.
Decision Date1995-08-07
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD is the device name listed in this FDA 510(k) record. The listed applicant is Bioscience, Inc.. It received FDA 510(k) clearance on 1995-08-07 under 510(k) number K952471. 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 BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD?

BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Bioscience, Inc.. The 510(k) number is K952471.

When did BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD receive FDA 510(k) clearance?

BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD received FDA 510(k) clearance on 1995-08-07, under 510(k) number K952471.

Who is the listed applicant for BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD?

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 BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD?

The FDA product code for BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD 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 SYSTEMK955003BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACKK925098BIOFIX 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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