SEEPLATE CERVICAL PLATE SYSTEM— 510(k) K082037

Name: FDA 510(k) clearance K082037
Creator: U.S. Food and Drug Administration
Published: 2008-09-26

Substantially Equivalent

Amedica Corp.

FDA 510(k) clearance K082037 for SEEPLATE CERVICAL PLATE SYSTEM, Substantially Equivalent on 2008-09-26. Applicant: Amedica Corp.. Device class: 2.

Clearance details

Applicant: Amedica Corp.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2008-07-17
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, 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 Amedica Corp.

view all

K173453 — Valeo® C+CSC with Lumen Interbody Fusion Device2018-03-05
K161405 — Valeo II Interbody Fusion Device System2016-08-19
K143518 — Valeo Spacer System and Valeo II Interbody Fusion Device System2015-10-02
K142264 — Valeo C Spacer System, Valeo II C IBF Device2014-12-08
K142347 — Amedica Valeo II Interbody Fusion Device2014-11-18

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.