The following data is part of a premarket notification filed by Vertiflex, Inc. with the FDA for Octane Vertebral Body Replacement (vbr) System.
| Device ID | K082270 |
| 510k Number | K082270 |
| Device Name: | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | VERTIFLEX, INC. 1351 Calle Avanzado San Clemente, CA 92673 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler VERTIFLEX, INC. 1351 Calle Avanzado San Clemente, CA 92673 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996154505 | K082270 | 000 |
| 00840996154390 | K082270 | 000 |
| 00840996154406 | K082270 | 000 |
| 00840996154413 | K082270 | 000 |
| 00840996154420 | K082270 | 000 |
| 00840996154437 | K082270 | 000 |
| 00840996154444 | K082270 | 000 |
| 00840996154451 | K082270 | 000 |
| 00840996154468 | K082270 | 000 |
| 00840996154475 | K082270 | 000 |
| 00840996154482 | K082270 | 000 |
| 00840996154499 | K082270 | 000 |
| 00840996154383 | K082270 | 000 |