The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Xcel Anchor System.
Device ID | K023013 |
510k Number | K023013 |
Device Name: | STRYKER XCEL ANCHOR SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Contact | Alisa Miller |
Correspondent | Alisa Miller Stryker Endoscopy 5900 OPTICAL CT. San Jose, CA 95138 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-10 |
Decision Date | 2003-02-26 |
Summary: | summary |