The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Construx Mini Ptc Spacer System, Forza Ptc Spacer System, Pillar Sa Ptc Spacer System.
| Device ID | K200052 |
| 510k Number | K200052 |
| Device Name: | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Natalia Volosen |
| Correspondent | Natalia Volosen Orthofix Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-10 |
| Decision Date | 2020-04-09 |