Cleared Special

5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)

K022623 · Depuyacromed · Orthopedic
Aug 2002
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K022623 is an FDA 510(k) clearance for the 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM), a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on August 27, 2002, 20 days after receiving the submission on August 7, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K022623 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2002
Decision Date August 27, 2002
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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