Cleared Traditional

ANSPACH KNOTLESS ANCHOR

K052572 · The Anspach Effort, Inc. · Orthopedic
Dec 2005
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K052572 is an FDA 510(k) clearance for the ANSPACH KNOTLESS ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on December 5, 2005, 77 days after receiving the submission on September 19, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K052572 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2005
Decision Date December 05, 2005
Days to Decision 77 days
Submission Type Traditional
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