White Pearl Preferred Angle Anterior Cervical Plate— 510(k) K160522

Name: FDA 510(k) clearance K160522
Creator: U.S. Food and Drug Administration
Published: 2016-04-26

Substantially Equivalent

Osseus Fusion Systems, LLC

FDA 510(k) clearance K160522 for White Pearl Preferred Angle Anterior Cervical Plate, Substantially Equivalent on 2016-04-26. Applicant: Osseus Fusion Systems, LLC. Device class: 2.

Clearance details

Applicant: Osseus Fusion Systems, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2016-02-25
Decision date: 2016-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, 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 Osseus Fusion Systems, LLC

view all

K213590 — Blue Topaz Sacroiliac Screw System2022-03-01
K181347 — Aries® Lumbar Interbodies2018-08-15
K170844 — Gemini-C Hybrid Cervical Interbody System2017-07-03
K131810 — OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM2013-08-08

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 →

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