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FDA 510(k)

TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS

K-Number: K083912 · 2009-07-15

ApplicantTreu-Instrumente GmbH
Decision Date2009-07-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS is the device name listed in this FDA 510(k) record. The listed applicant is Treu-Instrumente GmbH. It received FDA 510(k) clearance on 2009-07-15 under 510(k) number K083912. 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 TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS?

TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS is a medical device that received FDA 510(k) clearance on 2009-07-15. The listed applicant is Treu-Instrumente GmbH. The 510(k) number is K083912.

When did TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS receive FDA 510(k) clearance?

TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS received FDA 510(k) clearance on 2009-07-15, under 510(k) number K083912.

Who is the listed applicant for TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS?

The FDA 510(k) record lists Treu-Instrumente GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS?

The FDA product code for TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS is HWC. This falls under the Cardiovascular category.

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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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