The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Small Stature Uss.
| Device ID | K994121 |
| 510k Number | K994121 |
| Device Name: | SMALL STATURE USS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Jonathan M Gilbert |
| Correspondent | Jonathan M Gilbert SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| 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 | 1999-12-06 |
| Decision Date | 2000-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981SD4981190 | K994121 | 000 |