The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Range Spinal System, Large Denali Screws.
| Device ID | K081381 |
| 510k Number | K081381 |
| Device Name: | RANGE SPINAL SYSTEM, LARGE DENALI SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal 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 | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-16 |
| Decision Date | 2008-06-13 |
| Summary: | summary |