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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 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 2019-08-28 under 510(k) 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. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K191399.

When did BIOLOX CONTOURA Ceramic Femoral Head receive FDA 510(k) clearance?

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

Who is the listed applicant for BIOLOX CONTOURA Ceramic Femoral Head?

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 BIOLOX CONTOURA Ceramic Femoral Head?

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

Other records listing Total Joint Othopedics, Inc. as applicant

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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.

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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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