The following data is part of a premarket notification filed by Depuy Motech Acromed with the FDA for Timx Low Back System.
| Device ID | K984348 |
| 510k Number | K984348 |
| Device Name: | TIMX LOW BACK SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Pam Corsillo |
| Correspondent | Pam Corsillo DEPUY MOTECH ACROMED 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034241463 | K984348 | 000 |
| 10705034005126 | K984348 | 000 |
| 10705034005119 | K984348 | 000 |
| 10705034005096 | K984348 | 000 |
| 10705034005072 | K984348 | 000 |
| 10705034005065 | K984348 | 000 |