The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Lite Plate System.
Device ID | K150449 |
510k Number | K150449 |
Device Name: | LITe Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
Contact | Garry T. Hayeck |
Correspondent | Garry T. Hayeck STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-20 |
Decision Date | 2015-03-20 |
Summary: | summary |