Cure OPEL-C Plate System
K-Number: K181543 · 2018-08-31
ApplicantMeditech Spine, LLC
Decision Date2018-08-31
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Cure OPEL-C Plate System is a medical device manufactured by Meditech Spine, LLC. It received FDA 510(k) clearance on 2018-08-31 under approval number K181543. 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 Cure OPEL-C Plate System?
Cure OPEL-C Plate System is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by Meditech Spine, LLC. The 510(k) number is K181543.
When was Cure OPEL-C Plate System approved by the FDA?
Cure OPEL-C Plate System received FDA 510(k) clearance on 2018-08-31, under approval number K181543.
What company makes Cure OPEL-C Plate System?
Cure OPEL-C Plate System is manufactured by Meditech Spine, LLC.
What is the FDA product code for Cure OPEL-C Plate System?
The FDA product code for Cure OPEL-C Plate System is KWQ.
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K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
K201136Cure Lumbar Plate System
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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.