ORTHOSPHERE

GUDID 00840420121769

WRIGHT MEDICAL TECHNOLOGY, INC.

Total wrist carpus prosthesis

• Primary Device ID: 00840420121769
• NIH Device Record Key: 66ef2cdd-3e64-4098-871c-98c01194721b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOSPHERE
• Version Model Number: 8530009
• 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
• 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

• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 9 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420121769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030319

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

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: 2015-10-01

On-Brand Devices [ORTHOSPHERE]

• 00840420121813: 8530014
• 00840420121806: 8530013
• 00840420121790: 8530012
• 00840420121783: 8530011
• 00840420121776: 8530010
• 00840420121769: 8530009
• 00840420199485: 8534114
• 00840420199478: 8534113
• 00840420199461: 8534112
• 00840420199454: 8534111
• 00840420199447: 8534110
• 00840420199430: 8534109
• 00840420199423: 8534012
• 00840420199416: 8534011
• 00840420199393: 8534004
• 00840420199386: 8534003
• 00840420199324: 8531020
• 00840420199317: 8531019
• 00840420199263: 8531012
• 00840420199256: 8531011
• 00840420199232: 8531009