The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for The Octane Straight Intervertebral Fusion Device, Ti Coated.
| Device ID | K150152 |
| 510k Number | K150152 |
| Device Name: | The Octane Straight Intervertebral Fusion Device, Ti Coated |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Dawn Davisson |
| Correspondent | Kenneth C Maxwell EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2015-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996177375 | K150152 | 000 |
| 00840996153621 | K150152 | 000 |
| 00840996153638 | K150152 | 000 |
| 00840996153645 | K150152 | 000 |
| 00840996153652 | K150152 | 000 |
| 00840996150309 | K150152 | 000 |
| 00840996153669 | K150152 | 000 |
| 00840996177283 | K150152 | 000 |
| 00840996177290 | K150152 | 000 |
| 00840996177306 | K150152 | 000 |
| 00840996177313 | K150152 | 000 |
| 00840996177320 | K150152 | 000 |
| 00840996177337 | K150152 | 000 |
| 00840996177344 | K150152 | 000 |
| 00840996177351 | K150152 | 000 |
| 00840996177368 | K150152 | 000 |
| 00840996153614 | K150152 | 000 |