Cleared Traditional

DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

K981670 · Depuy, Inc. · Orthopedic
Jun 1998
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K981670 is an FDA 510(k) clearance for the DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 22, 1998, 41 days after receiving the submission on May 12, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K981670 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1998
Decision Date June 22, 1998
Days to Decision 41 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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