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FDA 510(k)

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST

K-Number: K031203 · 2003-07-14

ApplicantDePuy Orthopaedics, Inc.
Decision Date2003-07-14
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K031203. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST?

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K031203.

When did BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST receive FDA 510(k) clearance?

BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST received FDA 510(k) clearance on 2003-07-14, under 510(k) number K031203.

Who is the listed applicant for BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST?

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

What is the FDA product code for BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST?

The FDA product code for BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST is JWJ.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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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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