FDA 510(k)

SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS

K-Number: K041591 · 2004-09-23

Decision Date2004-09-23

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS 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 2004-09-23 under 510(k) number K041591. 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-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS?

SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS is a medical device that received FDA 510(k) clearance on 2004-09-23. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K041591.

When did SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS receive FDA 510(k) clearance?

SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS received FDA 510(k) clearance on 2004-09-23, under 510(k) number K041591.

Who is the listed applicant for SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS?

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-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS?

The FDA product code for SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS is 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.