FDA 510(k)

ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)

K-Number: K950418 · 1995-06-15

Decision Date1995-06-15

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K950418. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)?

ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K950418.

When did ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) receive FDA 510(k) clearance?

ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) received FDA 510(k) clearance on 1995-06-15, under 510(k) number K950418.

Who is the listed applicant for ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)?

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

What is the FDA product code for ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)?

The FDA product code for ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) is JDI.

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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.