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FDA 510(k)

APEX REVISION KNEE SYSTEMS

K-Number: K112891 · 2012-02-29

ApplicantOmni Life Science, Inc.
Decision Date2012-02-29
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX REVISION KNEE SYSTEMS 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 2012-02-29 under 510(k) number K112891. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX REVISION KNEE SYSTEMS?

APEX REVISION KNEE SYSTEMS is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K112891.

When did APEX REVISION KNEE SYSTEMS receive FDA 510(k) clearance?

APEX REVISION KNEE SYSTEMS received FDA 510(k) clearance on 2012-02-29, under 510(k) number K112891.

Who is the listed applicant for APEX REVISION KNEE SYSTEMS?

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 APEX REVISION KNEE SYSTEMS?

The FDA product code for APEX REVISION KNEE SYSTEMS is JWH.

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Other records listing Omni Life Science, 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.

K191765OMNI TiN Coated Apex Knee™ SystemK152919OMNI Skirted HeadsK131472APEX KNEE MODULAR TIBIA SYSTEMK113242APEX ARC HIP STEMK111062APEX KNEE SYSTEM, APEX ALL POLY TIBIAK111193APEX ARC HIP STEM

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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