The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Gibralt Spine Systems Facet Screw 04.0,04.5.
| Device ID | K112097 |
| 510k Number | K112097 |
| Device Name: | GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 |
| Classification | System, Facet Screw Spinal Device |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-11-21 |
| Summary: | summary |