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FDA 510(k)

SCORPIO CR SUPERFLEX TIBIAL INSERT

K-Number: K011643 · 2001-06-28

ApplicantHowmedica Osteonics Corp.
Decision Date2001-06-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCORPIO CR SUPERFLEX TIBIAL INSERT 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 2001-06-28 under 510(k) number K011643. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCORPIO CR SUPERFLEX TIBIAL INSERT?

SCORPIO CR SUPERFLEX TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K011643.

When did SCORPIO CR SUPERFLEX TIBIAL INSERT receive FDA 510(k) clearance?

SCORPIO CR SUPERFLEX TIBIAL INSERT received FDA 510(k) clearance on 2001-06-28, under 510(k) number K011643.

Who is the listed applicant for SCORPIO CR SUPERFLEX TIBIAL INSERT?

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 SCORPIO CR SUPERFLEX TIBIAL INSERT?

The FDA product code for SCORPIO CR SUPERFLEX TIBIAL INSERT is JWH.

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Related Devices (Code: JWH)

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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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