Cleared Special

HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)

K232005 · Smith & Nephew, Inc. · Orthopedic
Aug 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K232005 is an FDA 510(k) clearance for the HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid), a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on August 4, 2023, 29 days after receiving the submission on July 6, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K232005 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2023
Decision Date August 04, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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