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FDA 510(k)

BIONX DISTAL RADIUS SCREW

K-Number: K974876 · 1998-03-20

ApplicantBionx Implants, Inc.
Decision Date1998-03-20
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIONX DISTAL RADIUS SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 1998-03-20 under 510(k) number K974876. 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 BIONX DISTAL RADIUS SCREW?

BIONX DISTAL RADIUS SCREW is a medical device that received FDA 510(k) clearance on 1998-03-20. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K974876.

When did BIONX DISTAL RADIUS SCREW receive FDA 510(k) clearance?

BIONX DISTAL RADIUS SCREW received FDA 510(k) clearance on 1998-03-20, under 510(k) number K974876.

Who is the listed applicant for BIONX DISTAL RADIUS SCREW?

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

What is the FDA product code for BIONX DISTAL RADIUS SCREW?

The FDA product code for BIONX DISTAL RADIUS SCREW is MAI.

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Other records listing Bionx Implants, 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.

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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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