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FDA 510(k)

OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM

K-Number: K953961 · 1995-11-29

ApplicantOsteonics Corp.
Decision Date1995-11-29
Product CodeFWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K953961. The device is classified under product code FWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM?

OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Osteonics Corp.. The 510(k) number is K953961.

When did OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM receive FDA 510(k) clearance?

OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM received FDA 510(k) clearance on 1995-11-29, under 510(k) number K953961.

Who is the listed applicant for OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM?

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 OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM?

The FDA product code for OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM is FWW.

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Other records listing Osteonics Corp. as applicant

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Related Devices (Code: FWW)

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.

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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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