Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length

K-Number: K213580 · 2021-12-03

ApplicantTotal Joint Othopedics, Inc.
Decision Date2021-12-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2021-12-03 under approval number K213580. 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 Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is a medical device that received FDA 510(k) clearance on 2021-12-03. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K213580.

When was Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length approved by the FDA?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length received FDA 510(k) clearance on 2021-12-03, under approval number K213580.

What company makes Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is manufactured by Total Joint Othopedics, Inc..

What is the FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

The FDA product code for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length is LZO.

Other Devices by Total Joint Othopedics, Inc.

K161073Klassic HD Hip System K171962Klassic HD® Hip System K191399BIOLOX CONTOURA Ceramic Femoral Head K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System K243991Klassic Knee System - Revision Tibial Baseplate

View all 7 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.

↑