The following data is part of a premarket notification filed by Orthofix with the FDA for Construx Mini Peek Ti Spacer System.
| Device ID | K121649 |
| 510k Number | K121649 |
| Device Name: | CONSTRUX MINI PEEK TI SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ORTHOFIX 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Natalia Volosen |
| Correspondent | Natalia Volosen ORTHOFIX 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-11-29 |
| Summary: | summary |