Cleared Traditional

ANSPACH SUTURE ANCHOR

K981688 · The Anspach Effort, Inc. · Orthopedic
Jul 1998
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K981688 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 July 13, 1998, 63 days after receiving the submission on May 11, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K981688 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1998
Decision Date July 13, 1998
Days to Decision 63 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