The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System.
| Device ID | K070229 |
| 510k Number | K070229 |
| Device Name: | RANGE SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| 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 | 2007-01-24 |
| Decision Date | 2007-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857213906 | K070229 | 000 |
| 10888857011625 | K070229 | 000 |
| 10888857011649 | K070229 | 000 |
| 10888857011656 | K070229 | 000 |
| 10888857011687 | K070229 | 000 |
| 10888857011762 | K070229 | 000 |
| 10888857012011 | K070229 | 000 |
| 10888857012028 | K070229 | 000 |
| 10888857012035 | K070229 | 000 |
| 10888857012042 | K070229 | 000 |
| 10888857213845 | K070229 | 000 |
| 10888857007758 | K070229 | 000 |