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)

ENDO HEAD

K-Number: K111145 · 2011-08-16

ApplicantMedacta International
Decision Date2011-08-16
Product CodeLZY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENDO HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2011-08-16 under 510(k) number K111145. The device is classified under product code LZY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO HEAD?

ENDO HEAD is a medical device that received FDA 510(k) clearance on 2011-08-16. The listed applicant is Medacta International. The 510(k) number is K111145.

When did ENDO HEAD receive FDA 510(k) clearance?

ENDO HEAD received FDA 510(k) clearance on 2011-08-16, under 510(k) number K111145.

Who is the listed applicant for ENDO HEAD?

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 ENDO HEAD?

The FDA product code for ENDO HEAD is LZY.

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: LZY)

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.

K231448TANDEM Hip SystemSmith & Nephew, Inc.K974442PRE-POWDERED NITRILE EXAMINATION GLOVESP.T. Latexindo TobaperkasaK915528BHR BIPOLAR FEMORAL HEAD COMPONENTImplantology Corp.K915548IONGUARD TITANIUM MODULAR HEADSBiomet, Inc.K903084MODULAR CATHCART FRACTURE SYSTEMDepuy, Inc.K896580UNI-POLAR HEADRichards Medical Co., 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.

↑