The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Maestro System.
Device ID | K041754 |
510k Number | K041754 |
Device Name: | STRYKER MAESTRO SYSTEM |
Classification | Motor, Drill, Pneumatic |
Applicant | STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
Contact | Nicole Petty |
Correspondent | Nicole Petty STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
Product Code | HBB |
CFR Regulation Number | 882.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-06-29 |
Decision Date | 2004-09-07 |
Summary: | summary |