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 |