The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Gibralt Spinal System.
| Device ID | K110197 |
| 510k Number | K110197 |
| Device Name: | EXACTECH GIBRALT SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996170109 | K110197 | 000 |
| 00840996169844 | K110197 | 000 |
| 00840996169851 | K110197 | 000 |
| 00840996169868 | K110197 | 000 |
| 00840996169875 | K110197 | 000 |
| 00840996169882 | K110197 | 000 |
| 00840996169899 | K110197 | 000 |
| 00840996169905 | K110197 | 000 |
| 00840996169912 | K110197 | 000 |
| 00840996170024 | K110197 | 000 |
| 00840996170031 | K110197 | 000 |
| 00840996170048 | K110197 | 000 |
| 00840996170055 | K110197 | 000 |
| 00840996170062 | K110197 | 000 |
| 00840996170079 | K110197 | 000 |
| 00840996170086 | K110197 | 000 |
| 00840996170093 | K110197 | 000 |
| 00840996166119 | K110197 | 000 |