THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS— 510(k) K091253

Name: FDA 510(k) clearance K091253
Creator: U.S. Food and Drug Administration
Published: 2009-06-04

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K091253 for THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS, Substantially Equivalent on 2009-06-04. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2009-04-29
Decision date: 2009-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, 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 K2m, Inc.

view all

K260546 — Q Pedicle Instruments2026-03-17
K253545 — Vulcan Spinal System2026-02-10
K252873 — Q Interbody Instruments2026-02-06
K211320 — CAPRI Corpectomy Cage System2022-02-24
K202528 — Cannulated Power Driver Attachment2020-10-26

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.