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FDA 510(k)

GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5

K-Number: K112097 · 2011-11-21

ApplicantExactech, Inc.
Decision Date2011-11-21
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2011-11-21 under 510(k) number K112097. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5?

GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 is a medical device that received FDA 510(k) clearance on 2011-11-21. The listed applicant is Exactech, Inc.. The 510(k) number is K112097.

When did GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 receive FDA 510(k) clearance?

GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 received FDA 510(k) clearance on 2011-11-21, under 510(k) number K112097.

Who is the listed applicant for GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5?

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

What is the FDA product code for GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5?

The FDA product code for GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 is MRW.

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Related Devices (Code: MRW)

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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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