The following data is part of a premarket notification filed by Stryker Leibinger Gmbh & Co. Kg with the FDA for Stryker Orthomap Precision Knee System.
| Device ID | K162341 |
| 510k Number | K162341 |
| Device Name: | Stryker OrthoMap Precision Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 Freiburg, DE D-79111 |
| Contact | N/a N/a |
| Correspondent | Calley Herzog Biologics Consulting Group, Inc. 400 N. Washington Street Suite 100 Alexandria, VA 22314 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2016-10-12 |
| Summary: | summary |