ClearanceBrief
Panels › Orthopedic › Product code JDZ · Class 1

Mixer, Cement, For Clinical Use

Regulation 888.4210

0510(k)s in 12 months (13 all time)
3recalls in 12 months (18 all time)
2recalls that name a 510(k)
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Top companies in JDZ

DateFirm and productCodeLinked 510(k)
Apr 29, 2026Heraeus Medical GmbH (Dental Division)
Heraeus, PALAMIX duo. Material Number: 66057897.
Open, Classified
JDZNone listed
Apr 29, 2026Heraeus Medical GmbH (Dental Division)
Heraeus, PALAMIX uno. Material Number: 66057893.
Open, Classified
JDZNone listed
Apr 24, 2026Zimmer, Inc.
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component
Open, Classified
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
Terminated
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Terminated
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Terminated
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (
Terminated
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Terminated
JDZNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Terminated
JDZNone listed
Nov 14, 2013Stryker Instruments Div. of Stryker Corporation
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-01
Terminated
JDZNone listed
Jan 25, 2012Stryker Instruments Div. of Stryker Corporation
Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI Part Number: 0505-585-000, Lot:11223012
Terminated
JDZK032945
K912190
Mar 11, 2011Medtronic Spine LLC, formerly Kyphon Inc
Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to tw
Terminated
JDZK033801
K041584
Jun 30, 2009Biomet, Inc.
Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and appl
Terminated
JDZNone listed
May 1, 2008Stryker Instruments Div. of Stryker Corporation
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 4
Terminated
JDZNone listed
Mar 11, 2008Stryker Instruments Div. of Stryker Corporation
Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Terminated
JDZNone listed
Mar 11, 2008Stryker Instruments Div. of Stryker Corporation
Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Terminated
JDZNone listed
Mar 11, 2008Stryker Instruments Div. of Stryker Corporation
Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Terminated
JDZNone listed
Mar 11, 2008Stryker Instruments Div. of Stryker Corporation
Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo
Terminated
JDZNone listed

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