The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Octane Straight, Octane Straight - Lordotic, Octane Straight I/r, Octane Straight I/r - Lordotic.
| Device ID | K130434 |
| 510k Number | K130434 |
| Device Name: | OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC |
| 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 | 2013-02-21 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996155762 | K130434 | 000 |
| 00840996155755 | K130434 | 000 |
| 00840996155748 | K130434 | 000 |
| 00840996155731 | K130434 | 000 |
| 00840996155724 | K130434 | 000 |
| 00840996155717 | K130434 | 000 |