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FDA 510(k)

IMMIX BONE GRAFT EXTENDER

K-Number: K013764 · 2002-05-16

ApplicantOsteogenics Biomedical, Inc.
Decision Date2002-05-16
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMMIX BONE GRAFT EXTENDER is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K013764. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMIX BONE GRAFT EXTENDER?

IMMIX BONE GRAFT EXTENDER is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K013764.

When did IMMIX BONE GRAFT EXTENDER receive FDA 510(k) clearance?

IMMIX BONE GRAFT EXTENDER received FDA 510(k) clearance on 2002-05-16, under 510(k) number K013764.

Who is the listed applicant for IMMIX BONE GRAFT EXTENDER?

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

What is the FDA product code for IMMIX BONE GRAFT EXTENDER?

The FDA product code for IMMIX BONE GRAFT EXTENDER is KKY.

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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