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FDA 510(k)

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000

K-Number: K083469 · 2009-02-13

ApplicantMetasurg
Decision Date2009-02-13
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Metasurg. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K083469. 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 METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000?

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Metasurg. The 510(k) number is K083469.

When did METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 receive FDA 510(k) clearance?

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083469.

Who is the listed applicant for METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000?

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 CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000?

The FDA product code for METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 is KWD.

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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.

K123926METASURG NITINOL STAPLE IMPLANTK111265METASURG SUBTALAR IMPLANTK111536METASURG DIGIFUSE IMPLANTK070441METASURG SUBTALAR IMPLANT

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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