BIOARCH

GUDID 00840420128881

WRIGHT MEDICAL TECHNOLOGY, INC.

Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable

• Primary Device ID: 00840420128881
• NIH Device Record Key: 851cdb2a-424d-4761-828e-adc66ef7ae3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOARCH
• Version Model Number: ST1108
• 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: false
• 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
• 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: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 8 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420128881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070441

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

[00840420128881]

Moist Heat or Steam Sterilization

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 [BIOARCH]

• 00889797053242: ST1030
• 00840420128928: ST1112
• 00840420128911: ST1111
• 00840420128904: ST1110
• 00840420128898: ST1109
• 00840420128881: ST1108
• 00889797053228: Insertion Driver Subtalar System
• 00889797055482: Subtalar Implant Alignment Rod
• 00889797055475: Alignment Rod
• 00889797053235: Probe Subtalar System
• 00889797053297: Trial Sizer
• 00889797053280: Trial Sizer
• 00889797053273: Trial Sizer
• 00889797053266: Trial Sizer
• 00889797053259: Trial Sizer