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FDA 510(k)

Camber Spine Navigation System

K-Number: K220038 · 2022-04-29

ApplicantCamber Spine Technologies
Decision Date2022-04-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Camber Spine Navigation System is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2022-04-29 under approval number K220038. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Camber Spine Navigation System?

Camber Spine Navigation System is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Camber Spine Technologies. The 510(k) number is K220038.

When was Camber Spine Navigation System approved by the FDA?

Camber Spine Navigation System received FDA 510(k) clearance on 2022-04-29, under approval number K220038.

What company makes Camber Spine Navigation System?

Camber Spine Navigation System is manufactured by Camber Spine Technologies.

What is the FDA product code for Camber Spine Navigation System?

The FDA product code for Camber Spine Navigation System is OLO.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Camber Spine Technologies

K153720ENZA Zero-Profile Anterior Interbody Fusion K172446SPIRA-C Open Matrix Cervical Interbody K172064Ti-Diagon Oblique TLIF K170550Coveris Cervical Cage System K162986SPIRA Open Matrix ALIF K162121Siconus SI Joint Fixation System

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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