CD HORIZON SPINAL SYSTEM— 510(k) K131321

Name: FDA 510(k) clearance K131321
Creator: U.S. Food and Drug Administration
Published: 2013-06-05

Substantially Equivalent

Medtronic Sofamor Danek USA

FDA 510(k) clearance K131321 for CD HORIZON SPINAL SYSTEM, Substantially Equivalent on 2013-06-05. Applicant: Medtronic Sofamor Danek USA. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA
Product code: Code OSH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2013-05-08
Decision date: 2013-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSH

view all

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
K132575 — PASS LP SPINAL SYSTEM2013-10-03

More clearances from Medtronic Sofamor Danek USA

view all

K214010 — Anteralign Spinal System with Titan nanoLOCK Surface Technology2022-04-12
K170347 — CD HORIZON Fenestrated Screw Set2017-04-04
K133904 — CD HORIZON SPINAL SYSTEM GROWTH ROD SET2014-02-25
K132111 — CD HORIZON SPINAL SYSTEM2013-08-06
K123978 — CAPSTONE L SPINAL SYSTEM2013-04-09

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