Cleared Traditional

ANSPACH SUTURE ANCHOR

K965069 · The Anspach Effort, Inc. · Orthopedic
Feb 1997
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K965069 is an FDA 510(k) clearance for the ANSPACH SUTURE 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 February 12, 1997, 61 days after receiving the submission on December 13, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K965069 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1996
Decision Date February 12, 1997
Days to Decision 61 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

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