The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Octane Elevate Spinal Implant System.
| Device ID | K123607 |
| 510k Number | K123607 |
| Device Name: | OCTANE ELEVATE SPINAL IMPLANT SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2014-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996153607 | K123607 | 000 |
| 00840996153461 | K123607 | 000 |
| 00840996153478 | K123607 | 000 |
| 00840996153485 | K123607 | 000 |
| 00840996153492 | K123607 | 000 |
| 00840996153508 | K123607 | 000 |
| 00840996153515 | K123607 | 000 |
| 00840996153522 | K123607 | 000 |
| 00840996153539 | K123607 | 000 |
| 00840996153560 | K123607 | 000 |
| 00840996153577 | K123607 | 000 |
| 00840996153584 | K123607 | 000 |
| 00840996153591 | K123607 | 000 |
| 00840996153454 | K123607 | 000 |