The following data is part of a premarket notification filed by Sintea Plustek with the FDA for Plif Lite And Tlif Lite.
| Device ID | K132907 |
| 510k Number | K132907 |
| Device Name: | PLIF LITE AND TLIF LITE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SINTEA PLUSTEK 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen SINTEA PLUSTEK 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-17 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057432565722 | K132907 | 000 |
| 08057432560819 | K132907 | 000 |
| 08057432560826 | K132907 | 000 |
| 08057432560833 | K132907 | 000 |
| 08057432560840 | K132907 | 000 |
| 08057432560857 | K132907 | 000 |
| 08057432560864 | K132907 | 000 |
| 08057432560871 | K132907 | 000 |
| 08057432560888 | K132907 | 000 |
| 08057432565685 | K132907 | 000 |
| 08057432565692 | K132907 | 000 |
| 08057432565708 | K132907 | 000 |
| 08057432565715 | K132907 | 000 |
| 08057432560802 | K132907 | 000 |