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FDA 510(k)

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM

K-Number: K060536 · 2006-06-02

ApplicantOsteomed LP
Decision Date2006-06-02
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2006-06-02 under 510(k) number K060536. 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 OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM?

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-02. The listed applicant is Osteomed LP. The 510(k) number is K060536.

When did OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM receive FDA 510(k) clearance?

OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM received FDA 510(k) clearance on 2006-06-02, under 510(k) number K060536.

Who is the listed applicant for OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM?

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

What is the FDA product code for OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM?

The FDA product code for OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM is KWD.

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Other records listing Osteomed LP as applicant

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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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