The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Cougar Ls Lateral Cage System.
| Device ID | K110454 |
| 510k Number | K110454 |
| Device Name: | COUGAR LS LATERAL CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kevin G Stevens |
| Correspondent | Kevin G Stevens JOHNSON & JOHNSON 325 PARAMOUNT DR. 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 | 2011-02-16 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034291925 | K110454 | 000 |
| 10705034291277 | K110454 | 000 |
| 10705034291215 | K110454 | 000 |
| 10705034291192 | K110454 | 000 |
| 10705034291185 | K110454 | 000 |
| 10705034291031 | K110454 | 000 |
| 10705034290973 | K110454 | 000 |
| 10705034290911 | K110454 | 000 |
| 10705034290904 | K110454 | 000 |
| 10705034290881 | K110454 | 000 |
| 10705034290843 | K110454 | 000 |
| 10705034291321 | K110454 | 000 |
| 10705034291383 | K110454 | 000 |
| 10705034291420 | K110454 | 000 |
| 10705034291857 | K110454 | 000 |
| 10705034291796 | K110454 | 000 |
| 10705034291741 | K110454 | 000 |
| 10705034291680 | K110454 | 000 |
| 10705034291666 | K110454 | 000 |
| 10705034291659 | K110454 | 000 |
| 10705034291611 | K110454 | 000 |
| 10705034291550 | K110454 | 000 |
| 10705034291505 | K110454 | 000 |
| 10705034291444 | K110454 | 000 |
| 10705034290812 | K110454 | 000 |