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FDA 510(k)

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING

K-Number: K081876 · 2008-08-01

ApplicantOsteomed LP
Decision Date2008-08-01
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2008-08-01 under 510(k) number K081876. 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 RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING?

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING is a medical device that received FDA 510(k) clearance on 2008-08-01. The listed applicant is Osteomed LP. The 510(k) number is K081876.

When did OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING receive FDA 510(k) clearance?

OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING received FDA 510(k) clearance on 2008-08-01, under 510(k) number K081876.

Who is the listed applicant for OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING?

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 RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING?

The FDA product code for OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING is KWD.

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Other records listing Osteomed LP 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.

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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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