The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Orthomap Versatile Hip System.
| Device ID | K162937 |
| 510k Number | K162937 |
| Device Name: | Stryker OrthoMap Versatile Hip System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49001 |
| Contact | Brittney Larsen |
| Correspondent | Calley Herzog Biologics Consulting Group 400 N Washington St. 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 | 2016-10-20 |
| Decision Date | 2017-02-23 |
| Summary: | summary |