PEEK-OPTIMA ALIF SPACER— 510(k) K081636

Name: FDA 510(k) clearance K081636
Creator: U.S. Food and Drug Administration
Published: 2008-08-07

Substantially Equivalent

Biomet Spine

FDA 510(k) clearance K081636 for PEEK-OPTIMA ALIF SPACER, Substantially Equivalent on 2008-08-07. Applicant: Biomet Spine. Device class: 2.

Clearance details

Applicant: Biomet Spine
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2008-06-11
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, 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 Biomet Spine

view all

K152622 — Alta ACDF System2016-07-08
K151974 — Polaris Spinal System2015-11-13
K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System2015-08-12
K151224 — Lineum OCT Spine System2015-06-30
K141791 — BIOMET FUSION SYSTEM2014-10-09

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.