Gibralt Spine Systems Facet Screw 04.0,04.5
FDA 510(k) K112097 · Exactech, Inc.
510(k) numberK112097
Submission
- Device name
- Gibralt Spine Systems Facet Screw 04.0,04.5
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- July 22, 2011
- Decision date
- November 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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Questions and answers
When was Gibralt Spine Systems Facet Screw 04.0,04.5 cleared by the FDA?
Gibralt Spine Systems Facet Screw 04.0,04.5 (K112097) received a 510(k) decision of Substantially Equivalent on November 21, 2011, 122 days after the submission was received.
What is the product code of K112097?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.