The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Cross-pinned Interference Screw System.
Device ID | K012270 |
510k Number | K012270 |
Device Name: | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM |
Classification | Pin, Fixation, Threaded |
Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
Contact | Alisa Miller |
Correspondent | Alisa Miller Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-19 |
Decision Date | 2001-09-28 |
Summary: | summary |