The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Interference Screw Cross Pin System.
| Device ID | K020097 |
| 510k Number | K020097 |
| Device Name: | STRYKER INTERFERENCE SCREW CROSS PIN 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 | 2002-01-10 |
| Decision Date | 2002-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540392237 | K020097 | 000 |
| 04546540392220 | K020097 | 000 |