Cleared Traditional

K101835 - MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
(FDA 510(k) Clearance)

K101835 · Porex Surgical, Inc. · Neurology
Dec 2010
Decision
155d
Days
Class 2
Risk

K101835 is an FDA 510(k) clearance for the MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079, a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on December 3, 2010, 155 days after receiving the submission on July 1, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.

Submission Details

510(k) Number K101835 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2010
Decision Date December 03, 2010
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBW — Fastener, Plate, Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5360

Similar Devices — HBW Fastener, Plate, Cranioplasty

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251472 · Inion OY · Jul 2025
Stryker Resorbable Fixation System
K231208 · Stryker Leibinger GmbH & Co KG · Aug 2023
Stryker Universal Neuro III System AXS Screw
K171152 · Stryker · May 2017
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
K151387 · Stryker · Jun 2015
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · Depuy Synthes Companies of Johnson & Johnson · Mar 2015
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
K001353 · Biomedical Ent., Inc. · Mar 2001