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FDA 510(k)

TRYPTIK2C-plate Anterior Cervical Plate System

K-Number: K153042 · 2016-03-28

ApplicantSpineart
Decision Date2016-03-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRYPTIK2C-plate Anterior Cervical Plate System is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2016-03-28 under approval number K153042. 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 TRYPTIK2C-plate Anterior Cervical Plate System?

TRYPTIK2C-plate Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2016-03-28. It is manufactured by Spineart. The 510(k) number is K153042.

When was TRYPTIK2C-plate Anterior Cervical Plate System approved by the FDA?

TRYPTIK2C-plate Anterior Cervical Plate System received FDA 510(k) clearance on 2016-03-28, under approval number K153042.

What company makes TRYPTIK2C-plate Anterior Cervical Plate System?

TRYPTIK2C-plate Anterior Cervical Plate System is manufactured by Spineart.

What is the FDA product code for TRYPTIK2C-plate Anterior Cervical Plate System?

The FDA product code for TRYPTIK2C-plate Anterior Cervical Plate System is KWQ.

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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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