The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Cervical Stand Alone System.
| Device ID | K132999 |
| 510k Number | K132999 |
| Device Name: | CERVICAL STAND ALONE SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, 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 | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2014-04-14 |
| Summary: | summary |