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)

ORTHOMET RESURFACING FEMORAL COMPONENT

K-Number: K944752 · 1994-12-28

ApplicantOrthomet, Inc.
Decision Date1994-12-28
Product CodeKXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMET RESURFACING FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1994-12-28 under 510(k) number K944752. The device is classified under product code KXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOMET RESURFACING FEMORAL COMPONENT?

ORTHOMET RESURFACING FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Orthomet, Inc.. The 510(k) number is K944752.

When did ORTHOMET RESURFACING FEMORAL COMPONENT receive FDA 510(k) clearance?

ORTHOMET RESURFACING FEMORAL COMPONENT received FDA 510(k) clearance on 1994-12-28, under 510(k) number K944752.

Who is the listed applicant for ORTHOMET RESURFACING FEMORAL COMPONENT?

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

What is the FDA product code for ORTHOMET RESURFACING FEMORAL COMPONENT?

The FDA product code for ORTHOMET RESURFACING FEMORAL COMPONENT is KXA.

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 Orthomet, Inc. 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSERK931333ORTHOMET ACETABULAR CUP SYSTEM

View all 60 devices →

Related Devices (Code: KXA)

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.

K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLCK092198CORMET CEMENTLESS RESURFACING FEMORAL HEADCorin USAK082673CONSERVE PRESSFIT FEMORAL COMPONENTWrightmedicaltechnologyincK071053RECAP HA PRESS-FIT FEMORAL RESURFACING HEADBiomet, Inc.K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbHK062960CONSERVE FEMORAL RESURFACING COMPONENTWrightmedicaltechnologyinc

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.

↑