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)

VERSAFITCUP CC TRIO-ADDITIONAL LINERS

K-Number: K120531 · 2012-04-18

ApplicantMedacta International
Decision Date2012-04-18
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERSAFITCUP CC TRIO-ADDITIONAL LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-04-18 under 510(k) number K120531. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAFITCUP CC TRIO-ADDITIONAL LINERS?

VERSAFITCUP CC TRIO-ADDITIONAL LINERS is a medical device that received FDA 510(k) clearance on 2012-04-18. The listed applicant is Medacta International. The 510(k) number is K120531.

When did VERSAFITCUP CC TRIO-ADDITIONAL LINERS receive FDA 510(k) clearance?

VERSAFITCUP CC TRIO-ADDITIONAL LINERS received FDA 510(k) clearance on 2012-04-18, under 510(k) number K120531.

Who is the listed applicant for VERSAFITCUP CC TRIO-ADDITIONAL LINERS?

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

What is the FDA product code for VERSAFITCUP CC TRIO-ADDITIONAL LINERS?

The FDA product code for VERSAFITCUP CC TRIO-ADDITIONAL LINERS is LZO.

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 Medacta International 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.

K160605MectaLIF Anterior Stand-AloneK160289MasterLoc StemK153664M.U.S.T. Pedicle Screw SystemK133630GMK SHORT STEMK132878M.U.S.T. EXTENSIONK131518MECTACER BIOLOX OPTION HEADS

View all 28 devices →

Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.

↑