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FDA 510(k)

KIRSCHNER (K-WIRE), STEINMAN PINS

K-Number: K945670 · 1995-03-07

ApplicantBrasseler USA I, L.P.
Decision Date1995-03-07
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSCHNER (K-WIRE), STEINMAN PINS is the device name listed in this FDA 510(k) record. The listed applicant is Brasseler USA I, L.P.. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K945670. 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 KIRSCHNER (K-WIRE), STEINMAN PINS?

KIRSCHNER (K-WIRE), STEINMAN PINS is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Brasseler USA I, L.P.. The 510(k) number is K945670.

When did KIRSCHNER (K-WIRE), STEINMAN PINS receive FDA 510(k) clearance?

KIRSCHNER (K-WIRE), STEINMAN PINS received FDA 510(k) clearance on 1995-03-07, under 510(k) number K945670.

Who is the listed applicant for KIRSCHNER (K-WIRE), STEINMAN PINS?

The FDA 510(k) record lists Brasseler USA I, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIRSCHNER (K-WIRE), STEINMAN PINS?

The FDA product code for KIRSCHNER (K-WIRE), STEINMAN PINS is JDW.

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Other records listing Brasseler USA I, L.P. as applicant

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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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, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

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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