The following data is part of a premarket notification filed by Johnson And Johnson with the FDA for Concorde Bullet Cage System.
| Device ID | K103488 |
| 510k Number | K103488 |
| Device Name: | CONCORDE BULLET CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOHNSON AND JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Kevin G Stevens |
| Correspondent | Kevin G Stevens JOHNSON AND JOHNSON 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-03-02 |
| Summary: | summary |