SI-BONE

GUDID 00840420145741

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00840420145741
• NIH Device Record Key: 3d6322eb-95b4-4f1c-ac89-db1d1388d338
• Commercial Distribution Discontinuation: 2015-11-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SI-BONE
• Version Model Number: RETIRED
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter
• Length: 50 Millimeter
• Width: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420145741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080398

FDA Product Code

• OUR: Sacroiliac joint fixation

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: 2015-10-15

On-Brand Devices [SI-BONE]

• 00840420148858: RETIRED
• 00840420148438: RETIRED
• 00840420145741: RETIRED
• 00840420145734: RETIRED
• 00840420145727: RETIRED
• 00840420145710: RETIRED