FDA 510(k)

INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET

K-Number: K101976 · 2010-09-14

Decision Date2010-09-14

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET is the device name listed in this FDA 510(k) record. The listed applicant is Omni Life Science, Inc.. It received FDA 510(k) clearance on 2010-09-14 under 510(k) number K101976. 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 INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET?

INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K101976.

When did INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET receive FDA 510(k) clearance?

INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET received FDA 510(k) clearance on 2010-09-14, under 510(k) number K101976.

Who is the listed applicant for INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET?

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

What is the FDA product code for INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET?

The FDA product code for INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET is LPH.

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Related Devices (Code: LPH)

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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.