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FDA 510(k)

Resolve Anterior Cervical Plate System

K-Number: K251436 · 2025-07-11

ApplicantPioneer Surgical Technology, Inc.
Decision Date2025-07-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Resolve Anterior Cervical Plate System is a medical device manufactured by Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K251436. 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 Resolve Anterior Cervical Plate System?

Resolve Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Pioneer Surgical Technology, Inc.. The 510(k) number is K251436.

When was Resolve Anterior Cervical Plate System approved by the FDA?

Resolve Anterior Cervical Plate System received FDA 510(k) clearance on 2025-07-11, under approval number K251436.

What company makes Resolve Anterior Cervical Plate System?

Resolve Anterior Cervical Plate System is manufactured by Pioneer Surgical Technology, Inc..

What is the FDA product code for Resolve Anterior Cervical Plate System?

The FDA product code for Resolve Anterior Cervical Plate System is KWQ.

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Other Devices by Pioneer Surgical Technology, Inc.

K192396Streamline MIS Spinal Fixation System K211408CervAlign® Anterior Cervical Plate System K222493CODA™ Anterior Cervical Plate System

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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