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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B030NAV11702 K220038 000
B030NAVNEO7500 K220038 000
B030NAVNEO8000 K220038 000
B030NAVNEO8500 K220038 000
B030ORMNAV4501 K220038 000
B030ORMNAV5000 K220038 000
B030ORMNAV5500 K220038 000
B030ORMNAV5501 K220038 000
B030ORMNAV6500 K220038 000
B030ORMNAV6501 K220038 000
B030NAVNEO7000 K220038 000
B030NAVNEO6500 K220038 000
B030NAVNEO6000 K220038 000
B030NAV11704 K220038 000
B030NAV1170501 K220038 000
B030NAV50000101 K220038 000
B030NAV50000102 K220038 000
B030NAVNEO11701 K220038 000
B030NAVNEO4000 K220038 000
B030NAVNEO4500 K220038 000
B030NAVNEO5000 K220038 000
B030NAVNEO5500 K220038 000
B030ORMNAV7500 K220038 000
B030ORMNAV7501 K220038 000
B030ORTNAV8501 K220038 000
B030ORTNAVAWL4000 K220038 000
B030ORTNAVAWL4500 K220038 000
B030ORTNAVAWL5500 K220038 000
B030ORTNAVAWL6500 K220038 000
B030ORTNAVAWL7500 K220038 000
B030ORTNAVAWL8500 K220038 000
B030ORTNAVPEDAWL001 K220038 000
B030ORTNAVPROBE001 K220038 000
B030ORTNAV8500 K220038 000
B030ORTNAV7501 K220038 000
B030ORTNAV7500 K220038 000
B030ORMNAV8500 K220038 000
B030ORMNAV8501 K220038 000
B030ORTNAV4000 K220038 000
B030ORTNAV4500 K220038 000
B030ORTNAV4501 K220038 000
B030ORTNAV5500 K220038 000
B030ORTNAV5501 K220038 000
B030ORTNAV6500 K220038 000
B030ORTNAV6501 K220038 000
B030ORTNAVPROBE003 K220038 000

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