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FDA 510(k)

COLS® FIXATION SYSTEM

K-Number: K120740 · 2013-03-05

ApplicantFournitures Hospitalieres Industrie
Decision Date2013-03-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLS® FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2013-03-05 under 510(k) number K120740. 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 COLS® FIXATION SYSTEM?

COLS® FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-05. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K120740.

When did COLS® FIXATION SYSTEM receive FDA 510(k) clearance?

COLS® FIXATION SYSTEM received FDA 510(k) clearance on 2013-03-05, under 510(k) number K120740.

Who is the listed applicant for COLS® FIXATION SYSTEM?

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

What is the FDA product code for COLS® FIXATION SYSTEM?

The FDA product code for COLS® FIXATION SYSTEM is 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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