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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034412276 | K132324 | 000 |
| 10705034412627 | K132324 | 000 |
| 10705034412528 | K132324 | 000 |
| 10705034412504 | K132324 | 000 |
| 10705034412481 | K132324 | 000 |
| 10705034412467 | K132324 | 000 |
| 10705034412412 | K132324 | 000 |
| 10705034412399 | K132324 | 000 |
| 10705034412375 | K132324 | 000 |
| 10705034412351 | K132324 | 000 |
| 10705034412115 | K132324 | 000 |
| 10705034412108 | K132324 | 000 |
| 10705034412092 | K132324 | 000 |
| 10705034412634 | K132324 | 000 |
| 10705034412641 | K132324 | 000 |
| 10705034412269 | K132324 | 000 |
| 10705034412146 | K132324 | 000 |
| 10705034412139 | K132324 | 000 |
| 10705034412122 | K132324 | 000 |
| 10705034412030 | K132324 | 000 |
| 10705034412023 | K132324 | 000 |
| 10705034412016 | K132324 | 000 |
| 10705034411927 | K132324 | 000 |
| 10705034411910 | K132324 | 000 |
| 10705034411903 | K132324 | 000 |
| 10705034411897 | K132324 | 000 |
| 10705034411880 | K132324 | 000 |
| 10705034412085 | K132324 | 000 |