The following data is part of a premarket notification filed by Life Spine, Inc with the FDA for Anterior Lumbar Plate System (presidio).
| Device ID | K132589 |
| 510k Number | K132589 |
| Device Name: | ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis LIFE SPINE, INC 2401 W. HASSELL RD SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837021481 | K132589 | 000 |
| 00190837021320 | K132589 | 000 |
| 00190837021313 | K132589 | 000 |
| 00190837021306 | K132589 | 000 |
| 00190837021290 | K132589 | 000 |
| 00190837021283 | K132589 | 000 |
| 00190837021276 | K132589 | 000 |
| 00190837021269 | K132589 | 000 |
| 00190837021252 | K132589 | 000 |
| 00190837021245 | K132589 | 000 |
| 00190837021238 | K132589 | 000 |
| 00190837091521 | K132589 | 000 |
| 00190837091514 | K132589 | 000 |
| 00190837021337 | K132589 | 000 |
| 00190837021344 | K132589 | 000 |
| 00190837021351 | K132589 | 000 |
| 00190837021474 | K132589 | 000 |
| 00190837021467 | K132589 | 000 |
| 00190837021450 | K132589 | 000 |
| 00190837021443 | K132589 | 000 |
| 00190837021436 | K132589 | 000 |
| 00190837021429 | K132589 | 000 |
| 00190837021412 | K132589 | 000 |
| 00190837021405 | K132589 | 000 |
| 00190837021399 | K132589 | 000 |
| 00190837021382 | K132589 | 000 |
| 00190837021375 | K132589 | 000 |
| 00190837021368 | K132589 | 000 |
| 00190837082772 | K132589 | 000 |