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FDA 510(k)

PRE-LOADED ULTRAFIX RC

K-Number: K013553 · 2001-12-19

ApplicantLinvatec Corp.
Decision Date2001-12-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRE-LOADED ULTRAFIX RC is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2001-12-19 under 510(k) number K013553. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-LOADED ULTRAFIX RC?

PRE-LOADED ULTRAFIX RC is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is Linvatec Corp.. The 510(k) number is K013553.

When did PRE-LOADED ULTRAFIX RC receive FDA 510(k) clearance?

PRE-LOADED ULTRAFIX RC received FDA 510(k) clearance on 2001-12-19, under 510(k) number K013553.

Who is the listed applicant for PRE-LOADED ULTRAFIX RC?

The FDA 510(k) record lists Linvatec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-LOADED ULTRAFIX RC?

The FDA product code for PRE-LOADED ULTRAFIX RC is MBI.

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Related Devices (Code: MBI)

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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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