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FDA 510(k)

APEX FIXATION PINS

K-Number: K011136 · 2001-05-04

ApplicantHowmedica Osteonics Corp.
Decision Date2001-05-04
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX FIXATION PINS 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 2001-05-04 under 510(k) number K011136. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX FIXATION PINS?

APEX FIXATION PINS is a medical device that received FDA 510(k) clearance on 2001-05-04. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K011136.

When did APEX FIXATION PINS receive FDA 510(k) clearance?

APEX FIXATION PINS received FDA 510(k) clearance on 2001-05-04, under 510(k) number K011136.

Who is the listed applicant for APEX FIXATION PINS?

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 APEX FIXATION PINS?

The FDA product code for APEX FIXATION PINS is JDW.

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Related Devices (Code: JDW)

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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