VALEO SPACER SYSTEM— 510(k) K091278

Name: FDA 510(k) clearance K091278
Creator: U.S. Food and Drug Administration
Published: 2010-01-28

Substantially Equivalent

Amedica Corp.

FDA 510(k) clearance K091278 for VALEO SPACER SYSTEM, Substantially Equivalent on 2010-01-28. Applicant: Amedica Corp.. Device class: 2.

Clearance details

Applicant: Amedica Corp.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2009-05-01
Decision date: 2010-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

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 MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.