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FDA 510(k)

OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES

K-Number: K123908 · 2013-07-31

ApplicantMatrix Surgical USA
Decision Date2013-07-31
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Surgical USA. It received FDA 510(k) clearance on 2013-07-31 under 510(k) number K123908. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES?

OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2013-07-31. The listed applicant is Matrix Surgical USA. The 510(k) number is K123908.

When did OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES receive FDA 510(k) clearance?

OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES received FDA 510(k) clearance on 2013-07-31, under 510(k) number K123908.

Who is the listed applicant for OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES?

The FDA 510(k) record lists Matrix Surgical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES?

The FDA product code for OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES is KKY.

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTCeremed , Inc.

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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