DeviceClearance

ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System— 510(k) K181846

Substantially Equivalent

Globus Medical, Inc.

FDA 510(k) clearance K181846 for ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System, Substantially Equivalent on 2018-11-06. Applicant: Globus Medical, Inc.. Device class: 2.

Clearance details

Applicant
Globus Medical, Inc.
Product code
Code KWQ
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Audubon, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KWQ

view all

More clearances from Globus Medical, Inc.

view all

Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

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

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