The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System.
| Device ID | K141147 |
| 510k Number | K141147 |
| Device Name: | RANGE 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857112605 | K141147 | 000 |
| 10888857112360 | K141147 | 000 |
| 10888857112438 | K141147 | 000 |
| 10888857112469 | K141147 | 000 |
| 10888857112544 | K141147 | 000 |
| 10888857112551 | K141147 | 000 |
| 10888857112568 | K141147 | 000 |
| 10888857112575 | K141147 | 000 |
| 10888857112582 | K141147 | 000 |
| 10888857112599 | K141147 | 000 |
| 10888857112339 | K141147 | 000 |