The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Centurion Poct System.
| Device ID | K131833 |
| 510k Number | K131833 |
| Device Name: | CENTURION POCT SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Jacki Geren |
| Correspondent | Jacki Geren ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2014-01-30 |
| Summary: | summary |