Cleared Traditional

DALL-MILES SYSTEM

K070170 · Stryker Orthopaedics · Orthopedic
Mar 2007
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K070170 is an FDA 510(k) clearance for the DALL-MILES SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on March 2, 2007, 43 days after receiving the submission on January 18, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K070170 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2007
Decision Date March 02, 2007
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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