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FDA 510(k)

APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]

K-Number: K080842 · 2008-05-23

ApplicantOmni Life Science, Inc.
Decision Date2008-05-23
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] 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 2008-05-23 under 510(k) number K080842. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]?

APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Omni Life Science, Inc.. The 510(k) number is K080842.

When did APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] receive FDA 510(k) clearance?

APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] received FDA 510(k) clearance on 2008-05-23, under 510(k) number K080842.

Who is the listed applicant for APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]?

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, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES]?

The FDA product code for APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] is MBH.

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Other records listing Omni Life Science, Inc. as applicant

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K191765OMNI TiN Coated Apex Knee™ SystemK152919OMNI Skirted HeadsK131472APEX KNEE MODULAR TIBIA SYSTEMK112891APEX REVISION KNEE SYSTEMSK113242APEX ARC HIP STEMK111062APEX KNEE SYSTEM, APEX ALL POLY TIBIA

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Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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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