Cleared Traditional

ABG II MONOLITHIC HIP STEM

K110807 · Stryker Corp. · Orthopedic
May 2011
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K110807 is an FDA 510(k) clearance for the ABG II MONOLITHIC HIP STEM, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish (Class II — Special Controls, product code MAY), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on May 25, 2011, 63 days after receiving the submission on March 23, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K110807 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2011
Decision Date May 25, 2011
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAY — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3353