The following data is part of a premarket notification filed by Orthofix Us Llc with the FDA for 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, Newbridge Laminoplasty Fixation System, Cetra Anterior Cervical Plate System.
| Device ID | K211712 |
| 510k Number | K211712 |
| Device Name: | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Orthofix US LLC 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Jacki Koch |
| Correspondent | Jacki Koch Orthofix US LLC 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 | 2021-06-03 |
| Decision Date | 2022-02-11 |