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)

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT

K-Number: K070061 · 2007-01-31

ApplicantHayes Medical, Inc.
Decision Date2007-01-31
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Hayes Medical, Inc.. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K070061. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT?

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Hayes Medical, Inc.. The 510(k) number is K070061.

When did 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT receive FDA 510(k) clearance?

36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT received FDA 510(k) clearance on 2007-01-31, under 510(k) number K070061.

Who is the listed applicant for 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT?

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

What is the FDA product code for 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT?

The FDA product code for 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT is LWJ.

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 Hayes Medical, 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.

K062383UNISYN HA PLASMA MODULAR HIPK060635CONSENSUS ACETABULAR SHELL SYSTEMK030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMK030205CONSENSUS UNIPOLAR HEAD, COCRK021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENEK020153CONSENSUS ACETABLAR SHELL, TI COATED

View all 12 devices →

Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, Inc.

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.

↑