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FDA 510(k)

TruMatch Graft Cage - Long Bone

K-Number: K180821 · 2018-12-21

ApplicantSynthes (Usa), LLC
Decision Date2018-12-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TruMatch Graft Cage - Long Bone is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa), LLC. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K180821. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruMatch Graft Cage - Long Bone?

TruMatch Graft Cage - Long Bone is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Synthes (Usa), LLC. The 510(k) number is K180821.

When did TruMatch Graft Cage - Long Bone receive FDA 510(k) clearance?

TruMatch Graft Cage - Long Bone received FDA 510(k) clearance on 2018-12-21, under 510(k) number K180821.

Who is the listed applicant for TruMatch Graft Cage - Long Bone?

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

What is the FDA product code for TruMatch Graft Cage - Long Bone?

The FDA product code for TruMatch Graft Cage - Long Bone is HRS.

Other records listing Synthes (Usa), LLC 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.

K161417DePuy Synthes MAXFRAME Multi-Axial Correction System

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed 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 )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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