The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Universal Acl Instrumentation System.
| Device ID | K951267 |
| 510k Number | K951267 |
| Device Name: | STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-09-01 |