The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Concorde Curve System.
| Device ID | K103743 |
| 510k Number | K103743 |
| Device Name: | CONCORDE CURVE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | JOHNSON & JOHNSON 325 PARAMOUNT DR. Raynham, MA 02767 -0151 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang 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 | 2010-12-23 |
| Decision Date | 2011-03-17 |
| Summary: | summary |