The following data is part of a premarket notification filed by Depuy Spine with the FDA for Concorde Curve System.
| Device ID | K101923 |
| 510k Number | K101923 |
| Device Name: | CONCORDE CURVE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DEPUY SPINE 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang DEPUY SPINE 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 | 2010-07-09 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034138176 | K101923 | 000 |
| 10705034138008 | K101923 | 000 |
| 10705034138015 | K101923 | 000 |
| 10705034138022 | K101923 | 000 |
| 10705034138039 | K101923 | 000 |
| 10705034138046 | K101923 | 000 |
| 10705034138053 | K101923 | 000 |
| 10705034138114 | K101923 | 000 |
| 10705034138121 | K101923 | 000 |
| 10705034138138 | K101923 | 000 |
| 10705034138145 | K101923 | 000 |
| 10705034138152 | K101923 | 000 |
| 10705034138169 | K101923 | 000 |
| 10705034137995 | K101923 | 000 |