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FDA 510(k)

TRIMED OSTEOTOMY PLATE

K-Number: K043263 · 2005-01-14

ApplicantTriMed, Inc.
Decision Date2005-01-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIMED OSTEOTOMY PLATE is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2005-01-14 under 510(k) number K043263. 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 TRIMED OSTEOTOMY PLATE?

TRIMED OSTEOTOMY PLATE is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is TriMed, Inc.. The 510(k) number is K043263.

When did TRIMED OSTEOTOMY PLATE receive FDA 510(k) clearance?

TRIMED OSTEOTOMY PLATE received FDA 510(k) clearance on 2005-01-14, under 510(k) number K043263.

Who is the listed applicant for TRIMED OSTEOTOMY PLATE?

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 OSTEOTOMY PLATE?

The FDA product code for TRIMED OSTEOTOMY PLATE is HRS.

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Other records listing TriMed, Inc. as applicant

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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: 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.

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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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