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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 the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) 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. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K213580.

When did Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length receive FDA 510(k) clearance?

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

Who is the listed applicant for Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length?

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

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.

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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.

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