The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar Ls Lateral.
| Device ID | K140759 |
| 510k Number | K140759 |
| Device Name: | BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDOS INTERNATIONAL, SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Linda Bernier |
| Correspondent | Linda Bernier MEDOS INTERNATIONAL, SARL 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-06-13 |
| Summary: | summary |