The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Wedge Interference Screw System.
| Device ID | K972233 |
| 510k Number | K972233 |
| Device Name: | STRYKER WEDGE INTERFERENCE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Douglas M Lorang |
| Correspondent | Douglas M Lorang Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540754561 | K972233 | 000 |
| 04546540754554 | K972233 | 000 |
| 04546540754547 | K972233 | 000 |
| 04546540754530 | K972233 | 000 |
| 04546540754523 | K972233 | 000 |
| 04546540754516 | K972233 | 000 |