The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Construx Mini Peek; Spacer System, Ti Spacer System, Cervical Stand Alone System.
| Device ID | K142152 |
| 510k Number | K142152 |
| Device Name: | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE 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 | MQP |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-06 |
| Decision Date | 2015-01-08 |
| Summary: | summary |