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FDA 510(k)

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS

K-Number: K960023 · 1996-03-18

ApplicantPromex, Inc.
Decision Date1996-03-18
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1996-03-18 under 510(k) number K960023. 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 KIRSHNER WIRES (K-WIRE) & STEINMANN PINS?

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS is a medical device that received FDA 510(k) clearance on 1996-03-18. The listed applicant is Promex, Inc.. The 510(k) number is K960023.

When did KIRSHNER WIRES (K-WIRE) & STEINMANN PINS receive FDA 510(k) clearance?

KIRSHNER WIRES (K-WIRE) & STEINMANN PINS received FDA 510(k) clearance on 1996-03-18, under 510(k) number K960023.

Who is the listed applicant for KIRSHNER WIRES (K-WIRE) & STEINMANN PINS?

The FDA 510(k) record lists Promex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIRSHNER WIRES (K-WIRE) & STEINMANN PINS?

The FDA product code for KIRSHNER WIRES (K-WIRE) & STEINMANN PINS is JDW.

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Other records listing Promex, Inc. 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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