The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Power Adaptor Instrument Accessory.
Device ID | K120434 |
510k Number | K120434 |
Device Name: | POWER ADAPTOR INSTRUMENT ACCESSORY |
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 | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-13 |
Decision Date | 2012-03-08 |
Summary: | summary |