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 |