Cleared Special

PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW

K982900 · Depuy, Inc. · Orthopedic
Aug 1998
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K982900 is an FDA 510(k) clearance for the PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 31, 1998, 14 days after receiving the submission on August 17, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K982900 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1998
Decision Date August 31, 1998
Days to Decision 14 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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