The following data is part of a premarket notification filed by Stryker Corp with the FDA for Xia 4.5 Spinal System.
Device ID | K121342 |
510k Number | K121342 |
Device Name: | XIA 4.5 SPINAL SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | STRYKER CORP 2 PEARL COURT Allendale, NJ 07401 |
Contact | Tiffani Rogers |
Correspondent | Tiffani Rogers STRYKER CORP 2 PEARL COURT Allendale, NJ 07401 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Se - With Limitations (SESU) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-04 |
Decision Date | 2012-06-22 |
Summary: | summary |