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FDA 510(k)

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

K-Number: K094017 · 2010-03-05

ApplicantOmni Life Science, Inc.
Decision Date2010-03-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 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 2010-03-05 under 510(k) number K094017. 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 TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158?

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K094017.

When did TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 receive FDA 510(k) clearance?

TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K094017.

Who is the listed applicant for TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158?

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 TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158?

The FDA product code for TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 is JWH.

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Other records listing Omni Life Science, Inc. as applicant

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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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