The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst.
| Device ID | K132324 |
| 510k Number | K132324 |
| Device Name: | SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kirsten Lehmuller |
| Correspondent | Kirsten Lehmuller MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-26 |
| Decision Date | 2013-09-06 |
| Summary: | summary |