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FDA 510(k)

NORMED PELLEGRIN CALCANEUS STOP SCREW

K-Number: K133035 · 2013-12-13

ApplicantNormed Medizin-Technik GmbH
Decision Date2013-12-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NORMED PELLEGRIN CALCANEUS STOP SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Normed Medizin-Technik GmbH. It received FDA 510(k) clearance on 2013-12-13 under 510(k) number K133035. 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 NORMED PELLEGRIN CALCANEUS STOP SCREW?

NORMED PELLEGRIN CALCANEUS STOP SCREW is a medical device that received FDA 510(k) clearance on 2013-12-13. The listed applicant is Normed Medizin-Technik GmbH. The 510(k) number is K133035.

When did NORMED PELLEGRIN CALCANEUS STOP SCREW receive FDA 510(k) clearance?

NORMED PELLEGRIN CALCANEUS STOP SCREW received FDA 510(k) clearance on 2013-12-13, under 510(k) number K133035.

Who is the listed applicant for NORMED PELLEGRIN CALCANEUS STOP SCREW?

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

What is the FDA product code for NORMED PELLEGRIN CALCANEUS STOP SCREW?

The FDA product code for NORMED PELLEGRIN CALCANEUS STOP SCREW is HWC. This falls under the Cardiovascular category.

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Official Source

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