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FDA 510(k)

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03

K-Number: K003629 · 2001-02-22

ApplicantTerray Corp.
Decision Date2001-02-22
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 is the device name listed in this FDA 510(k) record. The listed applicant is Terray Corp.. It received FDA 510(k) clearance on 2001-02-22 under 510(k) number K003629. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03?

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 is a medical device that received FDA 510(k) clearance on 2001-02-22. The listed applicant is Terray Corp.. The 510(k) number is K003629.

When did MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 receive FDA 510(k) clearance?

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 received FDA 510(k) clearance on 2001-02-22, under 510(k) number K003629.

Who is the listed applicant for MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03?

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

What is the FDA product code for MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03?

The FDA product code for MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03 is KWD.

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Other records listing Terray Corp. 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.

K063275DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)K003911TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)K974030CARPAL ENGAGING WRIST FUSION PLATE

Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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