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FDA 510(k)

MECTACER BIOLOX OPTION HEADS

K-Number: K131518 · 2013-11-04

ApplicantMedacta International
Decision Date2013-11-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MECTACER BIOLOX OPTION HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2013-11-04 under 510(k) number K131518. 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 MECTACER BIOLOX OPTION HEADS?

MECTACER BIOLOX OPTION HEADS is a medical device that received FDA 510(k) clearance on 2013-11-04. The listed applicant is Medacta International. The 510(k) number is K131518.

When did MECTACER BIOLOX OPTION HEADS receive FDA 510(k) clearance?

MECTACER BIOLOX OPTION HEADS received FDA 510(k) clearance on 2013-11-04, under 510(k) number K131518.

Who is the listed applicant for MECTACER BIOLOX OPTION HEADS?

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 MECTACER BIOLOX OPTION HEADS?

The FDA product code for MECTACER BIOLOX OPTION HEADS 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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