The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Lite Plate System.
Device ID | K142699 |
510k Number | K142699 |
Device Name: | LITe Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Contact | Kristen Meany |
Correspondent | Garry T Hayeck STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-22 |
Decision Date | 2014-12-31 |
Summary: | summary |