The following data is part of a premarket notification filed by Life Spine with the FDA for Life Spine Anterior Cervical Plate System.
| Device ID | K070285 |
| 510k Number | K070285 |
| Device Name: | LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
| Contact | Rebecca M Brooks |
| Correspondent | Rebecca M Brooks LIFE SPINE 2400 HASSELL ROAD SUITE 370 Hoffman Estates, IL 60169 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-29 |
| Decision Date | 2007-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837032166 | K070285 | 000 |
| 00190837008093 | K070285 | 000 |
| 00190837008109 | K070285 | 000 |
| 00190837008116 | K070285 | 000 |
| 00190837008123 | K070285 | 000 |
| 00190837008130 | K070285 | 000 |
| 00190837008147 | K070285 | 000 |
| 00190837008154 | K070285 | 000 |
| 00190837008161 | K070285 | 000 |
| 00190837008086 | K070285 | 000 |
| 00190837008079 | K070285 | 000 |
| 00190837008062 | K070285 | 000 |
| 00190837036812 | K070285 | 000 |
| 00190837036829 | K070285 | 000 |
| 00190837036836 | K070285 | 000 |
| 00190837036843 | K070285 | 000 |
| 00190837036850 | K070285 | 000 |
| 00190837036867 | K070285 | 000 |
| 00190837036874 | K070285 | 000 |
| 00190837008055 | K070285 | 000 |
| 00190837008178 | K070285 | 000 |
| 00190837008185 | K070285 | 000 |
| 00190837008307 | K070285 | 000 |
| 00190837008314 | K070285 | 000 |
| 00190837008321 | K070285 | 000 |
| 00190837008338 | K070285 | 000 |
| 00190837008345 | K070285 | 000 |
| 00190837008352 | K070285 | 000 |
| 00190837008369 | K070285 | 000 |
| 00190837008376 | K070285 | 000 |
| 00190837008291 | K070285 | 000 |
| 00190837008284 | K070285 | 000 |
| 00190837008277 | K070285 | 000 |
| 00190837008192 | K070285 | 000 |
| 00190837008208 | K070285 | 000 |
| 00190837008215 | K070285 | 000 |
| 00190837008222 | K070285 | 000 |
| 00190837008239 | K070285 | 000 |
| 00190837008246 | K070285 | 000 |
| 00190837008253 | K070285 | 000 |
| 00190837008260 | K070285 | 000 |
| 00190837008383 | K070285 | 000 |