Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM

K-Number: K073065 · 2008-02-21

ApplicantOsteomed LP
Decision Date2008-02-21
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOMED METATARSAL RESURFACING 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 2008-02-21 under 510(k) number K073065. 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 METATARSAL RESURFACING IMPLANT SYSTEM?

OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Osteomed LP. The 510(k) number is K073065.

When did OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM receive FDA 510(k) clearance?

OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM received FDA 510(k) clearance on 2008-02-21, under 510(k) number K073065.

Who is the listed applicant for OSTEOMED METATARSAL RESURFACING 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 METATARSAL RESURFACING IMPLANT SYSTEM?

The FDA product code for OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM is KWD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMK123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORK123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMK120015OSTEOMED WRIST PLATING SYSTEMK111419OSTEOMED HAND FUSION SYSTEMK111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM

View all 27 devices →

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.

↑