FDA.report

510(k) K251436

Device
Resolve Anterior Cervical Plate System
Applicant
Pioneer Surgical Technology, Inc.
510(k) number
K251436
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-11
Date received
2025-05-08
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jaclyn Holli
Address
(D.B.A Resolve Surgical Technologies) 375 River Park Cir. Marquette MI US 49855 49855

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code KWQ

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K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
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K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14
K243369Cervical Plating SystemLife Spine, Inc.2024-12-11