The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Cougar System.
| Device ID | K113348 |
| 510k Number | K113348 |
| Device Name: | COUGAR SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOHNSON & JOHNSON 325 Paramount Drive Raynham, MA 02767 |
| Contact | Kevin G Stevens |
| Correspondent | Kevin G Stevens JOHNSON & JOHNSON 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 | 2011-11-14 |
| Decision Date | 2011-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034354569 | K113348 | 000 |
| 10705034354446 | K113348 | 000 |
| 10705034354453 | K113348 | 000 |
| 10705034354460 | K113348 | 000 |
| 10705034354477 | K113348 | 000 |
| 10705034354484 | K113348 | 000 |
| 10705034354491 | K113348 | 000 |
| 10705034354507 | K113348 | 000 |
| 10705034354514 | K113348 | 000 |
| 10705034354521 | K113348 | 000 |
| 10705034354538 | K113348 | 000 |
| 10705034354545 | K113348 | 000 |
| 10705034354552 | K113348 | 000 |
| 10705034354439 | K113348 | 000 |