The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Forza Spacer System.
| Device ID | K103111 |
| 510k Number | K103111 |
| Device Name: | FORZA SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Darla Chew |
| Correspondent | Darla Chew ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2011-03-23 |
| Summary: | summary |