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FDA 510(k)

EXACTECH GIBRALT SPINAL SYSTEM

K-Number: K110197 · 2011-07-15

ApplicantExactech, Inc.
Decision Date2011-07-15
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH GIBRALT SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2011-07-15 under 510(k) number K110197. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH GIBRALT SPINAL SYSTEM?

EXACTECH GIBRALT SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-15. The listed applicant is Exactech, Inc.. The 510(k) number is K110197.

When did EXACTECH GIBRALT SPINAL SYSTEM receive FDA 510(k) clearance?

EXACTECH GIBRALT SPINAL SYSTEM received FDA 510(k) clearance on 2011-07-15, under 510(k) number K110197.

Who is the listed applicant for EXACTECH GIBRALT SPINAL SYSTEM?

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 EXACTECH GIBRALT SPINAL SYSTEM?

The FDA product code for EXACTECH GIBRALT SPINAL SYSTEM is MNI.

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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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