PASS LP SPINAL SYSTEM— 510(k) K132575

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K132575 for PASS LP SPINAL SYSTEM, Substantially Equivalent on 2013-10-03. Applicant: Medicrea International. Device class: 2.

Clearance details

Applicant: Medicrea International
Product code: Code OSH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-08-16
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Neyron, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSH

K153446 — OLYMPIC Posterior Spinal Fixation System2016-04-08
K140276 — CD HORIZON SPINAL SYSTEM2014-03-13
K132574 — PASS LP SPINAL SYSTEM2013-11-08
K132303 — IMPLANET SPINE SYSTEM2013-10-10
K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM2013-09-12

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