The following data is part of a premarket notification filed by Vertiflex, Inc. with the FDA for Extended Vertiflex Spinal Screw System.
| Device ID | K073245 |
| 510k Number | K073245 |
| Device Name: | EXTENDED VERTIFLEX SPINAL SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | VERTIFLEX, INC. 1351 CALLE AVANZADA San Clamente, CA 92673 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler VERTIFLEX, INC. 1351 CALLE AVANZADA San Clamente, CA 92673 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996175005 | K073245 | 000 |
| 00840996174992 | K073245 | 000 |
| 00840996174985 | K073245 | 000 |
| 00840996174978 | K073245 | 000 |
| 00840996174961 | K073245 | 000 |
| 00840996174954 | K073245 | 000 |
| 00840996174947 | K073245 | 000 |
| 00840996174930 | K073245 | 000 |