The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Mesa And Range Spinal Systems.
| Device ID | K082769 |
| 510k Number | K082769 |
| Device Name: | MESA AND RANGE SPINAL SYSTEMS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857139022 | K082769 | 000 |
| 10888857138568 | K082769 | 000 |
| 10888857138469 | K082769 | 000 |
| 10888857138445 | K082769 | 000 |
| 10888857138421 | K082769 | 000 |
| 10888857138407 | K082769 | 000 |
| 10888857138384 | K082769 | 000 |
| 10888857138360 | K082769 | 000 |
| 10888857138346 | K082769 | 000 |
| 10888857138322 | K082769 | 000 |
| 10888857138308 | K082769 | 000 |
| 10888857138285 | K082769 | 000 |
| 10888857138261 | K082769 | 000 |
| 10888857138582 | K082769 | 000 |
| 10888857138605 | K082769 | 000 |
| 10888857138629 | K082769 | 000 |
| 10888857139008 | K082769 | 000 |
| 10888857138988 | K082769 | 000 |
| 10888857138964 | K082769 | 000 |
| 10888857138940 | K082769 | 000 |
| 10888857138841 | K082769 | 000 |
| 10888857138827 | K082769 | 000 |
| 10888857138803 | K082769 | 000 |
| 10888857138780 | K082769 | 000 |
| 10888857138766 | K082769 | 000 |
| 10888857138681 | K082769 | 000 |
| 10888857138667 | K082769 | 000 |
| 10888857138643 | K082769 | 000 |
| 10888857138247 | K082769 | 000 |