FDA 510(k)

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE

K-Number: K973163 · 1997-11-21

Decision Date1997-11-21

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973163. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACETABULAR SHELLS WITH MESH INGROWTH SURFACE?

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Howmedica Corp.. The 510(k) number is K973163.

When did ACETABULAR SHELLS WITH MESH INGROWTH SURFACE receive FDA 510(k) clearance?

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973163.

Who is the listed applicant for ACETABULAR SHELLS WITH MESH INGROWTH SURFACE?

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

What is the FDA product code for ACETABULAR SHELLS WITH MESH INGROWTH SURFACE?

The FDA product code for ACETABULAR SHELLS WITH MESH INGROWTH SURFACE is LPH.

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Other records listing Howmedica Corp. as applicant

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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.