The following data is part of a premarket notification filed by Vertiflex, Inc. with the FDA for Modified Vertiflex Spinal Screw System.
| Device ID | K073143 |
| 510k Number | K073143 |
| Device Name: | MODIFIED VERTIFLEX SPINAL SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | MNH |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-07 |
| Decision Date | 2008-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996170970 | K073143 | 000 |
| 00840996170857 | K073143 | 000 |
| 00840996170864 | K073143 | 000 |
| 00840996170871 | K073143 | 000 |
| 00840996170888 | K073143 | 000 |
| 00840996170895 | K073143 | 000 |
| 00840996170901 | K073143 | 000 |
| 00840996170918 | K073143 | 000 |
| 00840996170925 | K073143 | 000 |
| 00840996170932 | K073143 | 000 |
| 00840996170949 | K073143 | 000 |
| 00840996170956 | K073143 | 000 |
| 00840996170963 | K073143 | 000 |
| 00840996170840 | K073143 | 000 |