SUBTALAR SPACER SYSTEM

GUDID 00840420169488

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: 00840420169488
• NIH Device Record Key: 33f55dbc-f988-4e1a-bd98-42a18974c4f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUBTALAR SPACER SYSTEM
• Version Model Number: 03-008
• 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
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420169488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032682

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

Moist Heat or Steam Sterilization

[00840420169488]

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 [SUBTALAR SPACER SYSTEM]

• 00840420169518: 03-011
• 00840420169501: 03-010
• 00840420169495: 03-009
• 00840420169488: 03-008
• 00840420169471: 03-007
• 00840420169457: 01-011
• 00840420169440: 01-010
• 00840420169433: 01-009
• 00840420169426: 01-008
• 00840420169419: 01-007
• 00840420169402: 01-006
• 00889797037594: 02-009
• 00889797037587: 02-008
• 00889797037570: 02-007
• 00889797037563: 02-006
• 00889797037556: 02-005
• 00889797037549: 02-004