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FDA 510(k)

METASURG NITINOL STAPLE IMPLANT

K-Number: K123926 · 2013-05-03

ApplicantMetasurg
Decision Date2013-05-03
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METASURG NITINOL STAPLE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Metasurg. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K123926. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METASURG NITINOL STAPLE IMPLANT?

METASURG NITINOL STAPLE IMPLANT is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is Metasurg. The 510(k) number is K123926.

When did METASURG NITINOL STAPLE IMPLANT receive FDA 510(k) clearance?

METASURG NITINOL STAPLE IMPLANT received FDA 510(k) clearance on 2013-05-03, under 510(k) number K123926.

Who is the listed applicant for METASURG NITINOL STAPLE IMPLANT?

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

What is the FDA product code for METASURG NITINOL STAPLE IMPLANT?

The FDA product code for METASURG NITINOL STAPLE IMPLANT is JDR.

Related Clinical Trials

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Other records listing Metasurg 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.

K111265METASURG SUBTALAR IMPLANTK111536METASURG DIGIFUSE IMPLANTK083469METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000K070441METASURG SUBTALAR IMPLANT

Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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