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FDA 510(k)

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS

K-Number: K131264 · 2013-07-26

ApplicantGebr. Brasseler GmbH & Co. KG
Decision Date2013-07-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Gebr. Brasseler GmbH & Co. KG. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K131264. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS?

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Gebr. Brasseler GmbH & Co. KG. The 510(k) number is K131264.

When did KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS receive FDA 510(k) clearance?

KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131264.

Who is the listed applicant for KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS?

The FDA 510(k) record lists Gebr. Brasseler GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS?

The FDA product code for KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Gebr. Brasseler GmbH & Co. KG 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.

K071352CERADRILL

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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.

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