The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Patient Specific Cutting Guide.
| Device ID | K110533 |
| 510k Number | K110533 |
| Device Name: | STRYKER PATIENT SPECIFIC CUTTING GUIDE |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MBH |
| Subsequent Product Code | JWH |
| Subsequent Product Code | OOG |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-24 |
| Decision Date | 2011-05-19 |
| Summary: | summary |