Cleared Special

LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

K013557 · Walter Lorenz Surgical, Inc. · Orthopedic
Nov 2001
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K013557 is an FDA 510(k) clearance for the LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Walter Lorenz Surgical, Inc. (Warsaw,, US). The FDA issued a Cleared decision on November 16, 2001, 23 days after receiving the submission on October 24, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K013557 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2001
Decision Date November 16, 2001
Days to Decision 23 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