The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Cougar Ls 15 Lateral Cage System.
| Device ID | K122896 |
| 510k Number | K122896 |
| Device Name: | COUGAR LS 15 LATERAL CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034357041 | K122896 | 000 |
| 10705034356792 | K122896 | 000 |
| 10705034356730 | K122896 | 000 |
| 10705034356723 | K122896 | 000 |
| 10705034356716 | K122896 | 000 |
| 10705034356709 | K122896 | 000 |
| 10705034356662 | K122896 | 000 |
| 10705034356655 | K122896 | 000 |
| 10705034356648 | K122896 | 000 |
| 10705034356631 | K122896 | 000 |
| 10705034400570 | K122896 | 000 |
| 10705034400563 | K122896 | 000 |
| 10705034356808 | K122896 | 000 |
| 10705034356815 | K122896 | 000 |
| 10705034356822 | K122896 | 000 |
| 10705034357034 | K122896 | 000 |
| 10705034357027 | K122896 | 000 |
| 10705034357010 | K122896 | 000 |
| 10705034356976 | K122896 | 000 |
| 10705034356969 | K122896 | 000 |
| 10705034356952 | K122896 | 000 |
| 10705034356945 | K122896 | 000 |
| 10705034356891 | K122896 | 000 |
| 10705034356884 | K122896 | 000 |
| 10705034356877 | K122896 | 000 |
| 10705034356860 | K122896 | 000 |
| 10705034400556 | K122896 | 000 |