PEMF - SPINAL-STIM 5212CED

GUDID 18257200105700

5212CED, DEMO, OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200105700
• NIH Device Record Key: 712c0f12-e675-445b-84f2-684c1629b2a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEMF - SPINAL-STIM
• Version Model Number: 655212-0004
• Catalog Number: 5212CED
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200105700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P850007

FDA Product Code

• LOF: Stimulator, bone growth, non-invasive

Sterilization

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

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

[18257200105700]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [PEMF - SPINAL-STIM]

• 18257200133116: SUSPENDER, SPINAL STIM 5212/2212, ACCESSORY
• 18257200123926: 5212CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
• 18257200123902: 5212CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
• 18257200105700: 5212CED, DEMO, OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS
• 18257200105694: 5212CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS