Cleared Special

ISOLA POLYAXIAL WASHER

K013441 · Depuyacromed · Orthopedic
Nov 2001
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K013441 is an FDA 510(k) clearance for the ISOLA POLYAXIAL WASHER, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 16, 2001, 30 days after receiving the submission on October 17, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K013441 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2001
Decision Date November 16, 2001
Days to Decision 30 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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