SoftLink™ 16-10412

GUDID 03760154006316

The SoftLink™ Titanium Button w/Adjustable UHMWPE Loop device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use.

S.B.M

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03760154006316
• NIH Device Record Key: e896fbb6-d10c-435f-8ee9-b43ec0c236e0
• Commercial Distribution Discontinuation: 2020-01-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SoftLink™
• Version Model Number: Titanium Button w/Adjustable UHMWPE Loop - cortica
• Catalog Number: 16-10412
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us
• Phone: 781-369-1782
• Email: gboue@s-b-m.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760154006316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151004

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-10
• Device Publish Date: 2017-04-20

On-Brand Devices [SoftLink™]

• 03760154006323: The SoftLink™ Titanium Button w/Adjustable UHMWPE Loop device consists of an adjustable nonabs
• 03760154006316: The SoftLink™ Titanium Button w/Adjustable UHMWPE Loop device consists of an adjustable nonabs