The following data is part of a premarket notification filed by Exactech Sarasota with the FDA for Gibralt Rod-to-rod Cross Connectors.
| Device ID | K140645 |
| 510k Number | K140645 |
| Device Name: | GIBRALT ROD-TO-ROD CROSS CONNECTORS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | EXACTECH SARASOTA 7455 16th Street East Suite 105 Sarasota, FL 34243 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH SARASOTA 7455 16th Street East Suite 105 Sarasota, FL 34243 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-13 |
| Decision Date | 2014-04-11 |
| Summary: | summary |