Cleared Traditional

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

K152557 · G21, S.R.L. · Orthopedic
Feb 2016
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K152557 is an FDA 510(k) clearance for the Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on February 23, 2016, 168 days after receiving the submission on September 8, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K152557 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2015
Decision Date February 23, 2016
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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