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FDA 510(k)

BIOLOX delta Option and Extra-long Heads

K-Number: K173776 · 2018-07-06

Decision Date2018-07-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX delta Option and Extra-long Heads is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-07-06 under approval number K173776. 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 delta Option and Extra-long Heads?

BIOLOX delta Option and Extra-long Heads is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K173776.

When was BIOLOX delta Option and Extra-long Heads approved by the FDA?

BIOLOX delta Option and Extra-long Heads received FDA 510(k) clearance on 2018-07-06, under approval number K173776.

What company makes BIOLOX delta Option and Extra-long Heads?

BIOLOX delta Option and Extra-long Heads is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for BIOLOX delta Option and Extra-long Heads?

The FDA product code for BIOLOX delta Option and Extra-long Heads is LZO.

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Official Source

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