The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Eagle Plus Anterior Cervical Plate System, Eagle Plus Micro Anterior Cervical Plate System, Pulse Anterior Cervical Plate System, Skyline Anterior Cervical Plate System, Slim Loc Anterior Cervical Plate System, Swift Plus Anterior Cervical Plate Syst.
| Device ID | K171439 |
| 510k Number | K171439 |
| Device Name: | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate Syst |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Catherine Kilshaw |
| Correspondent | Sheree Geller DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2017-07-20 |
| Summary: | summary |