The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Depuy Spine Bengal, Concorde, Cougar, Devex And Leopard Systems.
| Device ID | K081917 |
| 510k Number | K081917 |
| Device Name: | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Sharon Starowicz |
| Correspondent | Sharon Starowicz DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2009-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034141107 | K081917 | 000 |
| 10705034140605 | K081917 | 000 |
| 10705034139876 | K081917 | 000 |
| 10705034139623 | K081917 | 000 |
| 10705034139616 | K081917 | 000 |
| 10705034139609 | K081917 | 000 |
| 10705034139593 | K081917 | 000 |
| 10705034139487 | K081917 | 000 |
| 10705034139470 | K081917 | 000 |
| 10705034139449 | K081917 | 000 |
| 10705034139319 | K081917 | 000 |
| 10705034140698 | K081917 | 000 |
| 10705034140971 | K081917 | 000 |
| 10705034141091 | K081917 | 000 |
| 10705034141084 | K081917 | 000 |
| 10705034141077 | K081917 | 000 |
| 10705034141060 | K081917 | 000 |
| 10705034141053 | K081917 | 000 |
| 10705034141046 | K081917 | 000 |
| 10705034141015 | K081917 | 000 |
| 10705034141008 | K081917 | 000 |
| 10705034140995 | K081917 | 000 |
| 10705034140988 | K081917 | 000 |
| 10705034139302 | K081917 | 000 |