Cleared Traditional

restor3d Metallic Interference Screw

K193491 · Restor3d · Orthopedic
Mar 2020
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K193491 is an FDA 510(k) clearance for the restor3d Metallic Interference Screw, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 19, 2020, 93 days after receiving the submission on December 17, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K193491 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date March 19, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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