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FDA 510(k)

TriMed Nitinol Staple System

K-Number: K190166 · 2019-07-01

ApplicantTriMed, Inc.
Decision Date2019-07-01
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriMed Nitinol Staple System is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K190166. 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 TriMed Nitinol Staple System?

TriMed Nitinol Staple System is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is TriMed, Inc.. The 510(k) number is K190166.

When did TriMed Nitinol Staple System receive FDA 510(k) clearance?

TriMed Nitinol Staple System received FDA 510(k) clearance on 2019-07-01, under 510(k) number K190166.

Who is the listed applicant for TriMed Nitinol Staple System?

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

What is the FDA product code for TriMed Nitinol Staple System?

The FDA product code for TriMed Nitinol Staple System is JDR.

Other records listing TriMed, Inc. 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.

K262344Large Compression ScrewsK262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )K261241TriMed Compression ScrewsK254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)K252061Distal Xtremities SystemK251134RipCord

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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.

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 ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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