The following data is part of a premarket notification filed by Elite Surgical Supplies (pty) Ltd. with the FDA for Modification To: Vertefix Pedicle Screw Spinal System.
| Device ID | K080075 |
| 510k Number | K080075 |
| Device Name: | MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE 1 Marietta, GA 30060 |
| Contact | Charise De Barros |
| Correspondent | Charise De Barros ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE 1 Marietta, GA 30060 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009708426222 | K080075 | 000 |
| 06009708426109 | K080075 | 000 |
| 06009708426093 | K080075 | 000 |
| 06009708426086 | K080075 | 000 |
| 06009708426079 | K080075 | 000 |
| 06009708426062 | K080075 | 000 |
| 06009708426055 | K080075 | 000 |
| 06009708426048 | K080075 | 000 |
| 06009708426031 | K080075 | 000 |
| 06009708426116 | K080075 | 000 |
| 06009708426123 | K080075 | 000 |
| 06009708426130 | K080075 | 000 |
| 06009708426215 | K080075 | 000 |
| 06009708426208 | K080075 | 000 |
| 06009708426192 | K080075 | 000 |
| 06009708426185 | K080075 | 000 |
| 06009708426178 | K080075 | 000 |
| 06009708426161 | K080075 | 000 |
| 06009708426154 | K080075 | 000 |
| 06009708426147 | K080075 | 000 |
| 06009708426024 | K080075 | 000 |