Stryker OrthoMap Versatile Hip System

Orthopedic Stereotaxic Instrument

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Orthomap Versatile Hip System.

Pre-market Notification Details

Device IDK162937
510k NumberK162937
Device Name:Stryker OrthoMap Versatile Hip System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Stryker Corporation 4100 E. Milham Ave. Kalamazoo,  MI  49001
ContactBrittney Larsen
CorrespondentCalley Herzog
Biologics Consulting Group 400 N Washington St. Suite 100 Alexandria,  VA  22314
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-20
Decision Date2017-02-23
Summary:summary

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