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Lactosorb Craniofacial Anchor-Push Screw

by Walter Lorenz Surgical, Inc. 510(k)

Active United States

510(k) K013557

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK013557 Date16 Nov 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lactosorb Craniofacial Anchor-Push Screw is a resorbable fixation device designed to assist resorbable sutures in craniofacial procedures. It is indicated for use in open and endoscopic brow lift surgeries.

The device is supplied as a single-use, sterile implant. It is MRI-safe and should be stored in a controlled environment. The product is authorized for use in the United States under FDA 510(k) clearance.

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