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FDA 510(k)

KINEMATIC II ROTATING HINGE KNEE

K-Number: K992346 · 1999-08-12

ApplicantHowmedica Osteonics Corp.
Decision Date1999-08-12
Product CodeLGE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KINEMATIC II ROTATING HINGE KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K992346. The device is classified under product code LGE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINEMATIC II ROTATING HINGE KNEE?

KINEMATIC II ROTATING HINGE KNEE is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K992346.

When did KINEMATIC II ROTATING HINGE KNEE receive FDA 510(k) clearance?

KINEMATIC II ROTATING HINGE KNEE received FDA 510(k) clearance on 1999-08-12, under 510(k) number K992346.

Who is the listed applicant for KINEMATIC II ROTATING HINGE KNEE?

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

What is the FDA product code for KINEMATIC II ROTATING HINGE KNEE?

The FDA product code for KINEMATIC II ROTATING HINGE KNEE is LGE.

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Related Devices (Code: LGE)

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.

K811630KINEMATIC ROTATING HINGE TOTAL KNEE PR.Howmedica Corp.

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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