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FDA 510(k)

Ozark(tm) Cervical Plate System

K-Number: K172104 · 2017-08-23

ApplicantK2m, Inc.
Decision Date2017-08-23
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ozark(tm) Cervical Plate System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2017-08-23 under approval number K172104. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ozark(tm) Cervical Plate System?

Ozark(tm) Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-08-23. It is manufactured by K2m, Inc.. The 510(k) number is K172104.

When was Ozark(tm) Cervical Plate System approved by the FDA?

Ozark(tm) Cervical Plate System received FDA 510(k) clearance on 2017-08-23, under approval number K172104.

What company makes Ozark(tm) Cervical Plate System?

Ozark(tm) Cervical Plate System is manufactured by K2m, Inc..

What is the FDA product code for Ozark(tm) Cervical Plate System?

The FDA product code for Ozark(tm) Cervical Plate System is KWQ.

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Other Devices by K2m, Inc.

K162664Pyrenees Cervical Plate System K162264Cascadia Interbody System K161028K2M Growing Spine System K160208NILE Alternative Fixation Spinal System K172009Cascadia Interbody System K171832Range/Denali/Mesa Spinal System

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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