The following data is part of a premarket notification filed by Elite Surgical Supplies (pty) Ltd. with the FDA for Vertefix Pedicle Screw Spinal System.
| Device ID | K063453 |
| 510k Number | K063453 |
| Device Name: | VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE I Marietta, GA 30060 |
| Contact | Charise De Barrios |
| Correspondent | Charise De Barrios ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE I Marietta, GA 30060 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-08-30 |
| Summary: | summary |