The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Xia® 4.5 Spinal System, Power Adaptor Instrument Accessory.
Device ID | K172724 |
510k Number | K172724 |
Device Name: | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
Contact | Priyanka Patel |
Correspondent | Priyanka Patel Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-11 |
Decision Date | 2017-10-10 |
Summary: | summary |