CervAlign Anterior Cervical Plate System— 510(k) K183060

Name: FDA 510(k) clearance K183060
Creator: U.S. Food and Drug Administration
Published: 2019-01-17

Substantially Equivalent

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

FDA 510(k) clearance K183060 for CervAlign Anterior Cervical Plate System, Substantially Equivalent on 2019-01-17. Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Device class: 2.

Clearance details

Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2018-11-02
Decision date: 2019-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marquette, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

view all

K201497 — EVOS Cabling System2020-10-28
K200095 — Streamline Navigated Instruments2020-06-26
K193468 — Tritium Sternal Cable Plate System2020-03-12
K192800 — Streamline TL Spinal Fixation System2020-01-14
K192718 — Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology2019-12-20

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K183060

K-number listed on FDA's recall record

Z-1218-2021 — CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 40mm Material Number: 66-240 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudathrosis, and failed previous fusion).Class II·Ongoing·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·20210115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183060.

Data sourced from openFDA. This site is unofficial and independent of the FDA.