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FDA 510(k)

BIOLOX delta Option and Extra-long Heads

K-Number: K173776 · 2018-07-06

ApplicantMicroport Orthopedics, Inc.
Decision Date2018-07-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX delta Option and Extra-long Heads is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) 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. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K173776.

When did BIOLOX delta Option and Extra-long Heads receive FDA 510(k) clearance?

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

Who is the listed applicant for BIOLOX delta Option and Extra-long Heads?

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

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

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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