The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Concorde Bullet Spinal System.
| Device ID | K110694 |
| 510k Number | K110694 |
| Device Name: | CONCORDE BULLET SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151 |
| Contact | Daphney Germain-kolawole |
| Correspondent | Daphney Germain-kolawole JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034285764 | K110694 | 000 |
| 10705034284392 | K110694 | 000 |
| 10705034284385 | K110694 | 000 |
| 10705034284378 | K110694 | 000 |
| 10705034141954 | K110694 | 000 |
| 10705034141930 | K110694 | 000 |
| 10705034141749 | K110694 | 000 |
| 10705034141725 | K110694 | 000 |
| 10705034141466 | K110694 | 000 |
| 10705034141459 | K110694 | 000 |
| 10705034141442 | K110694 | 000 |
| 10705034141435 | K110694 | 000 |
| 10705034141428 | K110694 | 000 |
| 10705034284408 | K110694 | 000 |
| 10705034284415 | K110694 | 000 |
| 10705034285702 | K110694 | 000 |
| 10705034284927 | K110694 | 000 |
| 10705034284903 | K110694 | 000 |
| 10705034284880 | K110694 | 000 |
| 10705034284798 | K110694 | 000 |
| 10705034284781 | K110694 | 000 |
| 10705034284774 | K110694 | 000 |
| 10705034284767 | K110694 | 000 |
| 10705034284545 | K110694 | 000 |
| 10705034284521 | K110694 | 000 |
| 10705034284507 | K110694 | 000 |
| 10705034284439 | K110694 | 000 |
| 10705034141411 | K110694 | 000 |