The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Construx Mini Peek Spacer System.
| Device ID | K101812 |
| 510k Number | K101812 |
| Device Name: | CONSTRUX MINI PEEK SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ORTHOFIX INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Contact | Russell Johnson |
| Correspondent | Russell Johnson ORTHOFIX INC. 1720 BRAY CENTRAL DR. Mckinney, TX 75069 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-09-27 |
| Summary: | summary |