The following data is part of a premarket notification filed by Stryker Corporate with the FDA for Styrker Orthomap Express Knee System.
| Device ID | K153240 |
| 510k Number | K153240 |
| Device Name: | Styrker OrthoMap Express Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | STRYKER CORPORATE BOETZINGER STR. 41 Freiburg, Baden-wuerttemberg, DE 79111 |
| Contact | Becky Ditty |
| Correspondent | Becky Ditty STRYKER CORPORATE 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-07-07 |
| Summary: | summary |