The following data is part of a premarket notification filed by Vertiflex (tm), Incorporated with the FDA for Vertiflex Octane Peek Vertebral Body Replacement (peek Vbr).
| Device ID | K070218 |
| 510k Number | K070218 |
| Device Name: | VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 Carlsbad, CA 92008 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 Carlsbad, CA 92008 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-23 |
| Decision Date | 2007-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996169172 | K070218 | 000 |
| 00840996155618 | K070218 | 000 |
| 00840996155601 | K070218 | 000 |
| 00840996155595 | K070218 | 000 |
| 00840996155588 | K070218 | 000 |
| 00840996155571 | K070218 | 000 |
| 00840996155564 | K070218 | 000 |
| 00840996155557 | K070218 | 000 |
| 00840996155540 | K070218 | 000 |
| 00840996155533 | K070218 | 000 |
| 00840996155526 | K070218 | 000 |
| 00840996155519 | K070218 | 000 |
| 00840996155502 | K070218 | 000 |
| 00840996155625 | K070218 | 000 |
| 00840996155632 | K070218 | 000 |
| 00840996155649 | K070218 | 000 |
| 00840996169165 | K070218 | 000 |
| 00840996169158 | K070218 | 000 |
| 00840996169141 | K070218 | 000 |
| 00840996169134 | K070218 | 000 |
| 00840996169127 | K070218 | 000 |
| 00840996160698 | K070218 | 000 |
| 00840996155700 | K070218 | 000 |
| 00840996155694 | K070218 | 000 |
| 00840996155687 | K070218 | 000 |
| 00840996155670 | K070218 | 000 |
| 00840996155663 | K070218 | 000 |
| 00840996155656 | K070218 | 000 |
| 00840996155496 | K070218 | 000 |