FDA 510(k)

SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS

K-Number: K111891 · 2011-11-28

Decision Date2011-11-28

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2011-11-28 under 510(k) number K111891. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS?

SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2011-11-28. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K111891.

When did SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS receive FDA 510(k) clearance?

SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS received FDA 510(k) clearance on 2011-11-28, under 510(k) number K111891.

Who is the listed applicant for SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS?

The FDA product code for SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS is HSB.

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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.