The following data is part of a premarket notification filed by Stryker Spine with the FDA for Stryker Xia 3 Power Adaptor.
Device ID | K200666 |
510k Number | K200666 |
Device Name: | Stryker Xia 3 Power Adaptor |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Contact | Megan Callanan |
Correspondent | Megan Callanan Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-13 |
Decision Date | 2020-04-23 |