Camber Spine Navigation System

Orthopedic Stereotaxic Instrument

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Camber Spine Navigation System.

Pre-market Notification Details

Device IDK220038
510k NumberK220038
Device Name:Camber Spine Navigation System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Camber Spine Technologies 501 Allendale Rd King Of Prussia,  PA  19406
ContactNoel Hetrick
CorrespondentChristine Scifert
MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial,  CO  80112
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-04-29

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