The following data is part of a premarket notification filed by Life Spine, Llc. with the FDA for Life Spine Neo Anterior Cervical Plate System.
| Device ID | K040844 |
| 510k Number | K040844 |
| Device Name: | LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | LIFE SPINE, LLC. 11965 EAST 65TH ST. SUITE 4 Indianapolis, IN 46236 |
| Contact | Michael S Butler |
| Correspondent | Michael S Butler LIFE SPINE, LLC. 11965 EAST 65TH ST. SUITE 4 Indianapolis, IN 46236 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-01 |
| Decision Date | 2004-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837008048 | K040844 | 000 |
| 00190837007836 | K040844 | 000 |
| 00190837007829 | K040844 | 000 |
| 00190837007812 | K040844 | 000 |
| 00190837007805 | K040844 | 000 |
| 00190837007799 | K040844 | 000 |
| 00190837007782 | K040844 | 000 |
| 00190837007775 | K040844 | 000 |
| 00190837007768 | K040844 | 000 |
| 00190837007751 | K040844 | 000 |
| 00190837007744 | K040844 | 000 |
| 00190837007737 | K040844 | 000 |
| 00190837007720 | K040844 | 000 |
| 00190837007713 | K040844 | 000 |
| 00190837035334 | K040844 | 000 |
| 00190837035327 | K040844 | 000 |
| 00190837035310 | K040844 | 000 |
| 00190837035303 | K040844 | 000 |
| 00190837007843 | K040844 | 000 |
| 00190837007850 | K040844 | 000 |
| 00190837007867 | K040844 | 000 |
| 00190837008031 | K040844 | 000 |
| 00190837008024 | K040844 | 000 |
| 00190837008017 | K040844 | 000 |
| 00190837008000 | K040844 | 000 |
| 00190837007997 | K040844 | 000 |
| 00190837007980 | K040844 | 000 |
| 00190837007973 | K040844 | 000 |
| 00190837007966 | K040844 | 000 |
| 00190837007959 | K040844 | 000 |
| 00190837007942 | K040844 | 000 |
| 00190837007935 | K040844 | 000 |
| 00190837007928 | K040844 | 000 |
| 00190837007911 | K040844 | 000 |
| 00190837007904 | K040844 | 000 |
| 00190837007898 | K040844 | 000 |
| 00190837007881 | K040844 | 000 |
| 00190837007874 | K040844 | 000 |
| 00190837035297 | K040844 | 000 |