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FDA 510(k)

CHROME COBALT BALL HEAD

K-Number: K962268 · 1996-10-23

ApplicantArtos Medical Products GmbH
Decision Date1996-10-23
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHROME COBALT BALL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Artos Medical Products GmbH. It received FDA 510(k) clearance on 1996-10-23 under 510(k) number K962268. 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 CHROME COBALT BALL HEAD?

CHROME COBALT BALL HEAD is a medical device that received FDA 510(k) clearance on 1996-10-23. The listed applicant is Artos Medical Products GmbH. The 510(k) number is K962268.

When did CHROME COBALT BALL HEAD receive FDA 510(k) clearance?

CHROME COBALT BALL HEAD received FDA 510(k) clearance on 1996-10-23, under 510(k) number K962268.

Who is the listed applicant for CHROME COBALT BALL HEAD?

The FDA 510(k) record lists Artos Medical Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROME COBALT BALL HEAD?

The FDA product code for CHROME COBALT BALL HEAD 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 Artos Medical Products GmbH 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.

K962034SC, CEMENTLESS HIP SYSTEMK962086CPS, CEMENTED CUP SYSTEMK961899CPS, CEMENTED HIP SYSTEM

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.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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