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FDA 510(k)

OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES

K-Number: K910083 · 1991-04-01

ApplicantOsteonics Corp.
Decision Date1991-04-01
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K910083. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES?

OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Osteonics Corp.. The 510(k) number is K910083.

When did OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES receive FDA 510(k) clearance?

OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES received FDA 510(k) clearance on 1991-04-01, under 510(k) number K910083.

Who is the listed applicant for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES?

The FDA 510(k) record lists Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES?

The FDA product code for OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES is HSX.

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Other records listing Osteonics Corp. as applicant

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Related Devices (Code: HSX)

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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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