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FDA 510(k)

METAL HEMI IMPLANT

K-Number: K071243 · 2007-05-23

ApplicantOrthopro, LLC
Decision Date2007-05-23
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL HEMI IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Orthopro, LLC. It received FDA 510(k) clearance on 2007-05-23 under 510(k) number K071243. 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 METAL HEMI IMPLANT?

METAL HEMI IMPLANT is a medical device that received FDA 510(k) clearance on 2007-05-23. The listed applicant is Orthopro, LLC. The 510(k) number is K071243.

When did METAL HEMI IMPLANT receive FDA 510(k) clearance?

METAL HEMI IMPLANT received FDA 510(k) clearance on 2007-05-23, under 510(k) number K071243.

Who is the listed applicant for METAL HEMI IMPLANT?

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

What is the FDA product code for METAL HEMI IMPLANT?

The FDA product code for METAL HEMI IMPLANT is KWD.

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Other records listing Orthopro, 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.

K122936ANKLE TRAUMA SYSTEMK113006I-FUSE HAMMER TOE SYSTEMSK093055CSTS SCREWK073228DC ULNAR SHORTENING SYSTEMK070555ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRESK062908ORTHROPRO HEMI TOE

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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

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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