The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Universal Cmf System.
Device ID | K022185 |
510k Number | K022185 |
Device Name: | UNIVERSAL CMF SYSTEM |
Classification | Plate, Bone |
Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49087 |
Contact | Wade T Rutkoskie |
Correspondent | Wade T Rutkoskie STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49087 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-03 |
Decision Date | 2002-12-17 |
Summary: | summary |