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 |