MAXAN ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K133518

Clearance details

Applicant

Biomet Spine (Aka Ebi, LLC)

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2013-11-15

Decision date

2014-11-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, US

• 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

• K140710 — BIOMET GRAFT DELIVERY SYRINGES2014-09-04
• K132373 — BIOMET ACCESS SYSTEM2014-03-27
• K133746 — POLARIS SPINAL SYSTEM2014-03-12
• K131615 — POLARIS SPINAL SYSTEM2013-09-04
• K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM2013-02-25

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 →

• Z-0203-2016 — MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.Class II·Terminated·Biomet Spine, LLC·20150929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133518.