FDA 510(k)

APEX PINS

K-Number: K061493 · 2006-07-07

Decision Date2006-07-07

Product CodeJDW

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

APEX PINS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Howmedica Osteonics. It received FDA 510(k) clearance on 2006-07-07 under 510(k) number K061493. 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 PINS?

APEX PINS is a medical device that received FDA 510(k) clearance on 2006-07-07. The listed applicant is Stryker Howmedica Osteonics. The 510(k) number is K061493.

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

APEX PINS received FDA 510(k) clearance on 2006-07-07, under 510(k) number K061493.

Who is the listed applicant for APEX PINS?

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

What is the FDA product code for APEX PINS?

The FDA product code for APEX PINS is JDW.

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC K241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.