The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Depuy Pulse Thoracolumbar Screw System.
| Device ID | K113396 |
| 510k Number | K113396 |
| Device Name: | DEPUY PULSE THORACOLUMBAR SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang MEDOS INTERNATIONAL SARL 325 Paramount Drive 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-07 |
| Decision Date | 2012-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034441320 | K113396 | 000 |
| 10705034389677 | K113396 | 000 |
| 10705034389653 | K113396 | 000 |
| 10705034389639 | K113396 | 000 |
| 10705034389615 | K113396 | 000 |
| 10705034389455 | K113396 | 000 |
| 10705034389431 | K113396 | 000 |
| 10705034389417 | K113396 | 000 |
| 10705034389394 | K113396 | 000 |
| 10705034389370 | K113396 | 000 |
| 10705034389202 | K113396 | 000 |
| 10705034389844 | K113396 | 000 |
| 10705034389868 | K113396 | 000 |
| 10705034389882 | K113396 | 000 |
| 10705034392233 | K113396 | 000 |
| 10705034392226 | K113396 | 000 |
| 10705034392219 | K113396 | 000 |
| 10705034392202 | K113396 | 000 |
| 10705034392196 | K113396 | 000 |
| 10705034392189 | K113396 | 000 |
| 10705034392172 | K113396 | 000 |
| 10705034392165 | K113396 | 000 |
| 10705034392141 | K113396 | 000 |
| 10705034390888 | K113396 | 000 |
| 10705034389189 | K113396 | 000 |