The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Modification To:expedium Spine System.
| Device ID | K101933 |
| 510k Number | K101933 |
| Device Name: | MODIFICATION TO:EXPEDIUM SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Daphney Germain |
| Correspondent | Daphney Germain DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034278339 | K101933 | 000 |
| 10705034278322 | K101933 | 000 |