Percusys®

GUDID 04250337104230

Percusys® Pedicle Screw polyaxial OD 5 x 35 mm, incl. Set Screw

Joimax GmbH

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 04250337104230
• NIH Device Record Key: eb750465-2780-41ae-8d89-4707d7480035
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Percusys®
• Version Model Number: JMPS0535PS
• Company DUNS: 344267187
• Company Name: Joimax GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49721255140
• Email: Quality@joimax.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250337104230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143200

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Percusys®]

• 04250337106142: Percusys® Rod Ti-Alloy OD 5.5 x 300 mm, straight
• 04250337106135: Percusys® Rod Ti-Alloy OD 5.5 x 280 mm, straight
• 04250337106128: Percusys® Rod Ti-Alloy OD 5.5 x 260 mm, straight
• 04250337106111: Percusys® Rod Ti-Alloy OD 5.5 x 240 mm, straight
• 04250337106104: Percusys® Rod Ti-Alloy OD 5.5 x 220 mm, straight
• 04250337106098: Percusys® Rod Ti-Alloy OD 5.5 x 200 mm, straight
• 04250337106081: Percusys® Rod Ti-Alloy OD 5.5 x 180 mm, straight
• 04250337106074: Percusys® Rod Ti-Alloy OD 5.5 x 160 mm, straight
• 04250337106067: Percusys® Rod Ti-Alloy OD 5.5 x 150 mm, straight
• 04250337106050: Percusys® Rod Ti-Alloy OD 5.5 x 140 mm, straight
• 04250337106043: Percusys® Rod Ti-Alloy OD 5.5 x 130 mm, straight
• 04250337104797: Percusys® Rod Ti-Alloy OD 5.5 x 120 mm, lordotic
• 04250337104780: Percusys® Rod Ti-Alloy OD 5.5 x 110 mm, lordotic
• 04250337104773: Percusys® Rod Ti-Alloy OD 5.5 x 100 mm, lordotic
• 04250337104766: Percusys® Rod Ti-Alloy OD 5.5 x 95 mm, lordotic
• 04250337104759: Percusys® Rod Ti-Alloy OD 5.5 x 90 mm, lordotic
• 04250337104742: Percusys® Rod Ti-Alloy OD 5.5 x 85 mm, lordotic
• 04250337104735: Percusys® Rod Ti-Alloy OD 5.5 x 80 mm, lordotic
• 04250337104728: Percusys® Rod Ti-Alloy OD 5.5 x 75 mm, lordotic
• 04250337104711: Percusys® Rod Ti-Alloy OD 5.5 x 70 mm, lordotic
• 04250337104704: Percusys® Rod Ti-Alloy OD 5.5 x 65 mm, lordotic
• 04250337104698: Percusys® Rod Ti-Alloy OD 5.5 x 60 mm, lordotic
• 04250337104681: Percusys® Rod Ti-Alloy OD 5.5 x 55 mm, lordotic
• 04250337104674: Percusys® Rod Ti-Alloy OD 5.5 x 50 mm, lordotic
• 04250337104667: Percusys® Rod Ti-Alloy OD 5.5 x 45 mm, lordotic
• 04250337104650: Percusys® Rod Ti-Alloy OD 5.5 x 40 mm, lordotic
• 04250337104643: Percusys® Rod Ti-Alloy OD 5.5 x 35 mm, lordotic
• 04250337104636: Percusys® Rod Ti-Alloy OD 5.5 x 30 mm, lordotic
• 04250337104629: Percusys® Pedicle Screw monoaxial OD 8 x 55 mm, incl. Set Screw
• 04250337104612: Percusys® Pedicle Screw monoaxial OD 8 x 50 mm, incl. Set Screw
• 04250337104605: Percusys® Pedicle Screw monoaxial OD 8 x 45 mm, incl. Set Screw
• 04250337104599: Percusys® Pedicle Screw monoaxial OD 8 x 40 mm, incl. Set Screw
• 04250337104582: Percusys® Pedicle Screw monoaxial OD 8 x 35 mm, incl. Set Screw
• 04250337104575: Percusys® Pedicle Screw monoaxial OD 7 x 55 mm, incl. Set Screw
• 04250337104568: Percusys® Pedicle Screw monoaxial OD 7 x 50 mm, incl. Set Screw
• 04250337104551: Percusys® Pedicle Screw monoaxial OD 7 x 45 mm, incl. Set Screw
• 04250337104544: Percusys® Pedicle Screw monoaxial OD 7 x 40 mm, incl. Set Screw
• 04250337104537: Percusys® Pedicle Screw monoaxial OD 7 x 35 mm, incl. Set Screw
• 04250337104520: Percusys® Pedicle Screw monoaxial OD 6 x 55 mm, incl. Set Screw
• 04250337104513: Percusys® Pedicle Screw monoaxial OD 6 x 50 mm, incl. Set Screw
• 04250337104506: Percusys® Pedicle Screw monoaxial OD 6 x 45 mm, incl. Set Screw
• 04250337104490: Percusys® Pedicle Screw monoaxial OD 6 x 40 mm, incl. Set Screw
• 04250337104483: Percusys® Pedicle Screw monoaxial OD 6 x 35 mm, incl. Set Screw
• 04250337104476: Percusys® Pedicle Screw monoaxial Ø 5 x 55 mm, incl. set screw
• 04250337104469: Percusys® Pedicle Screw monoaxial OD 5 x 50 mm, incl. Set Screw
• 04250337104452: Percusys® Pedicle Screw monoaxial OD 5 x 45 mm, incl. Set Screw
• 04250337104445: Percusys® Pedicle Screw monoaxial OD 5 x 40 mm, incl. Set Screw
• 04250337104438: Percusys® Pedicle Screw monoaxial OD 5 x 35 mm, incl. Set Screw
• 04250337104421: Percusys® Pedicle Screw polyaxial OD 8 x 55 mm, incl. Set Screw
• 04250337104414: Percusys® Pedicle Screw polyaxial OD 8 x 50 mm, incl. Set Screw