FDA 510(k)

RECON system - Compression Screws

K-Number: K151708 · 2016-03-02

Decision Date2016-03-02

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RECON system - Compression Screws is a medical device manufactured by Normed Medizin-Technik GmbH. It received FDA 510(k) clearance on 2016-03-02 under approval number K151708. 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 RECON system - Compression Screws?

RECON system - Compression Screws is a medical device that received FDA 510(k) clearance on 2016-03-02. It is manufactured by Normed Medizin-Technik GmbH. The 510(k) number is K151708.

When was RECON system - Compression Screws approved by the FDA?

RECON system - Compression Screws received FDA 510(k) clearance on 2016-03-02, under approval number K151708.

What company makes RECON system - Compression Screws?

RECON system - Compression Screws is manufactured by Normed Medizin-Technik GmbH.

What is the FDA product code for RECON system - Compression Screws?

The FDA product code for RECON system - Compression Screws is HWC. This falls under the Cardiovascular category.

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

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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.