The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Orthofix Acp (anterior Cervical Plate System).
| Device ID | K121658 |
| 510k Number | K121658 |
| Device Name: | ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Ally Baduel |
| Correspondent | Ally Baduel ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-07-20 |
| Summary: | summary |