The following data is part of a premarket notification filed by Orthofix Us Llc with the FDA for Forza Xp Expandable Spacer System.
| Device ID | K213951 |
| 510k Number | K213951 |
| Device Name: | FORZA XP Expandable Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Orthofix US LLC 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Natalia Volosen |
| Correspondent | Natalia Volosen Orthofix US LLC 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-01-05 |