LIGAPASS— 510(k) K132395

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K132395 for LIGAPASS, Substantially Equivalent on 2013-12-06. Applicant: Medicrea International. Device class: 2.

Clearance details

Applicant: Medicrea International
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2013-08-01
Decision date: 2013-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

K261374 — LigaPASS System2026-05-27
K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24

More clearances from Medicrea International

K220810 — Infinity OCT System and PASS OCT Spinal System2022-04-19
K220724 — CD Horizon Spinal System and PASS LP Spinal System2022-04-08
K180091 — UNiD Spine Analyzer2018-02-08
K170172 — UNiD Spine Analyzer2017-05-24
K153169 — PASS OCT Patient Specific Rods2016-01-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.