The following data is part of a premarket notification filed by Sintea Plustek, Llc with the FDA for Pls (posterior Lumbar System).
| Device ID | K140787 |
| 510k Number | K140787 |
| Device Name: | PLS (POSTERIOR LUMBAR SYSTEM) |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SINTEA PLUSTEK, LLC 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen SINTEA PLUSTEK, LLC 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| 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 | 2014-03-31 |
| Decision Date | 2014-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810086190867 | K140787 | 000 |
| 00810086190706 | K140787 | 000 |
| 00810086190713 | K140787 | 000 |
| 00810086190737 | K140787 | 000 |
| 00810086190874 | K140787 | 000 |
| 00810086190881 | K140787 | 000 |
| 00810086190898 | K140787 | 000 |
| 00810086191000 | K140787 | 000 |
| 00810086191055 | K140787 | 000 |
| 00810086191154 | K140787 | 000 |
| 00810086191161 | K140787 | 000 |
| 00810086193394 | K140787 | 000 |
| 00810086193400 | K140787 | 000 |
| 00810086193547 | K140787 | 000 |
| 00810086193554 | K140787 | 000 |
| 00810086193691 | K140787 | 000 |
| 00810086193714 | K140787 | 000 |
| 00810086190720 | K140787 | 000 |