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FDA 510(k)

BIOLOX CONTOURA Ceramic Femoral Head

K-Number: K191399 · 2019-08-28

ApplicantTotal Joint Othopedics, Inc.
Decision Date2019-08-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX CONTOURA Ceramic Femoral Head is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2019-08-28 under approval number K191399. 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 BIOLOX CONTOURA Ceramic Femoral Head?

BIOLOX CONTOURA Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K191399.

When was BIOLOX CONTOURA Ceramic Femoral Head approved by the FDA?

BIOLOX CONTOURA Ceramic Femoral Head received FDA 510(k) clearance on 2019-08-28, under approval number K191399.

What company makes BIOLOX CONTOURA Ceramic Femoral Head?

BIOLOX CONTOURA Ceramic Femoral Head is manufactured by Total Joint Othopedics, Inc..

What is the FDA product code for BIOLOX CONTOURA Ceramic Femoral Head?

The FDA product code for BIOLOX CONTOURA Ceramic Femoral Head is LZO.

Other Devices by Total Joint Othopedics, Inc.

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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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