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FDA 510(k)

APEX KNEE SYSTEM, APEX ALL POLY TIBIA

K-Number: K111062 · 2011-07-13

ApplicantOmni Life Science, Inc.
Decision Date2011-07-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX KNEE SYSTEM, APEX ALL POLY TIBIA 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 2011-07-13 under 510(k) number K111062. 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 KNEE SYSTEM, APEX ALL POLY TIBIA?

APEX KNEE SYSTEM, APEX ALL POLY TIBIA is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K111062.

When did APEX KNEE SYSTEM, APEX ALL POLY TIBIA receive FDA 510(k) clearance?

APEX KNEE SYSTEM, APEX ALL POLY TIBIA received FDA 510(k) clearance on 2011-07-13, under 510(k) number K111062.

Who is the listed applicant for APEX KNEE SYSTEM, APEX ALL POLY TIBIA?

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 KNEE SYSTEM, APEX ALL POLY TIBIA?

The FDA product code for APEX KNEE SYSTEM, APEX ALL POLY TIBIA 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 SYSTEMK112891APEX REVISION KNEE SYSTEMSK113242APEX ARC HIP STEMK111193APEX 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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