Synchfix 86SYN205

GUDID 00889797114882

Syndesmosis #5 Suture

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic fixation suture button

• Primary Device ID: 00889797114882
• NIH Device Record Key: f155a48d-c1cd-4ffc-94c3-cc133d8a801a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synchfix
• Version Model Number: 86SYN205
• Catalog Number: 86SYN205
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797114882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251643

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

• 00889797114882 - Synchfix: 2025-12-02Syndesmosis #5 Suture
• 00889797114882 - Synchfix: 2025-12-02 Syndesmosis #5 Suture
• 00889797111478 - Incompass Total Ankle System: 2025-09-08 Depth Gauge Proximal Tibia Cut
• 00889797111485 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged
• 00889797111492 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged
• 00889797111508 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged
• 00889797111515 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged
• 00889797111522 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged
• 00889797111539 - Incompass Total Ankle System: 2025-09-08 Trial Tibial Tray Pegged