The following data is part of a premarket notification filed by Vertiflex (tm), Incorporated with the FDA for Vertiflex Spinal Screw System.
| Device ID | K062670 |
| 510k Number | K062670 |
| Device Name: | VERTIFLEX SPINAL SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-07 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996170833 | K062670 | 000 |
| 00840996187374 | K062670 | 000 |
| 00840996187381 | K062670 | 000 |
| 00840996187398 | K062670 | 000 |
| 00840996157483 | K062670 | 000 |
| 00840996170147 | K062670 | 000 |
| 00840996170154 | K062670 | 000 |
| 00840996170161 | K062670 | 000 |
| 00840996170178 | K062670 | 000 |
| 00840996170185 | K062670 | 000 |
| 00840996170192 | K062670 | 000 |
| 00840996170765 | K062670 | 000 |
| 00840996170772 | K062670 | 000 |
| 00840996170789 | K062670 | 000 |
| 00840996170796 | K062670 | 000 |
| 00840996170802 | K062670 | 000 |
| 00840996170819 | K062670 | 000 |
| 00840996181297 | K062670 | 000 |