ClearanceBrief
Panels › Neurology › Product code GWO · Class 2

Plate, Cranioplasty, Preformed, Alterable

Regulation 882.5320

2510(k)s in 12 months (44 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
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Top companies in GWO

DateFirm and productCodeLinked 510(k)
May 8, 2024Stryker Leibinger GmbH & Co. KG
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Open, Classified
GWOK182425
Jul 7, 2023Osteomed, LLC
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Open, Classified
GWOK111176
Jul 7, 2023Osteomed, LLC
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Open, Classified
GWOK111176
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fi
Terminated
GWOK120352
Jun 22, 2018Stryker Leibinger GmbH & Co. KG
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid f
Terminated
GWOK120352
Aug 6, 2015Biomet Microfixation, LLC
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Terminated
GWOK121624
Aug 6, 2015Biomet Microfixation, LLC
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Terminated
GWOK121624
Apr 24, 2008Respironics, Inc.
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
GWOK922106

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