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FDA 510(k)

RECON system - Compression Screws

K-Number: K151708 · 2016-03-02

ApplicantNormed Medizin-Technik GmbH
Decision Date2016-03-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RECON system - Compression Screws 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 2016-03-02 under 510(k) 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. The listed applicant is Normed Medizin-Technik GmbH. The 510(k) number is K151708.

When did RECON system - Compression Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for RECON system - Compression Screws?

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 RECON system - Compression Screws?

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

Other records listing Normed Medizin-Technik GmbH 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.

K151701Tenodesis screw system

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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