The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range, Spinal System, Everest Spinal System.
| Device ID | K133944 |
| 510k Number | K133944 |
| Device Name: | RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857210660 | K133944 | 000 |
| 10888857053984 | K133944 | 000 |
| 10888857053991 | K133944 | 000 |
| 10888857054004 | K133944 | 000 |
| 10888857054028 | K133944 | 000 |
| 10888857054035 | K133944 | 000 |
| 10888857054042 | K133944 | 000 |
| 10888857054059 | K133944 | 000 |
| 10888857054066 | K133944 | 000 |
| 10888857053960 | K133944 | 000 |
| 10888857053953 | K133944 | 000 |
| 10888857008526 | K133944 | 000 |
| 10888857008533 | K133944 | 000 |
| 10888857008540 | K133944 | 000 |
| 10888857047709 | K133944 | 000 |
| 10888857053908 | K133944 | 000 |
| 10888857053915 | K133944 | 000 |
| 10888857053922 | K133944 | 000 |
| 10888857053939 | K133944 | 000 |
| 10888857054073 | K133944 | 000 |
| 10888857054080 | K133944 | 000 |
| 10888857054097 | K133944 | 000 |
| 10888857055322 | K133944 | 000 |
| 10888857055339 | K133944 | 000 |
| 10888857055346 | K133944 | 000 |
| 10888857055353 | K133944 | 000 |
| 10888857055360 | K133944 | 000 |
| 10888857055377 | K133944 | 000 |
| 10888857055384 | K133944 | 000 |
| 10888857055391 | K133944 | 000 |
| 10888857055308 | K133944 | 000 |
| 10888857055292 | K133944 | 000 |
| 10888857054103 | K133944 | 000 |
| 10888857055209 | K133944 | 000 |
| 10888857055216 | K133944 | 000 |
| 10888857055223 | K133944 | 000 |
| 10888857055230 | K133944 | 000 |
| 10888857055254 | K133944 | 000 |
| 10888857055261 | K133944 | 000 |
| 10888857055285 | K133944 | 000 |
| 10888857055407 | K133944 | 000 |