The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Titanium Cross-screw System, Model 234-500-1xx.
| Device ID | K011319 |
| 510k Number | K011319 |
| Device Name: | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX |
| Classification | Pin, Fixation, Threaded |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Ryan Yearsley |
| Correspondent | Ryan Yearsley 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 | 2001-05-01 |
| Decision Date | 2001-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540756787 | K011319 | 000 |
| 04546540756770 | K011319 | 000 |
| 04546540756763 | K011319 | 000 |