The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Acl Interference Screw System.
| Device ID | K952460 |
| 510k Number | K952460 |
| Device Name: | STRYKER ACL INTERFERENCE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Christina Vance |
| Correspondent | Christina Vance 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 | 1995-05-26 |
| Decision Date | 1995-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540756633 | K952460 | 000 |
| 04546540756626 | K952460 | 000 |
| 04546540756619 | K952460 | 000 |
| 04546540756602 | K952460 | 000 |
| 04546540756572 | K952460 | 000 |
| 04546540756541 | K952460 | 000 |