SPEEDFIX OM-7555

GUDID 00817470012118

SPEEDFIX ULTRA KIT 55X8.2MM

Smith & Nephew, Inc.

Tendon bone anchor, non-bioabsorbable Tendon bone anchor, non-bioabsorbable Tendon bone anchor, non-bioabsorbable

• Primary Device ID: 00817470012118
• NIH Device Record Key: 3eebebbd-7af8-45b0-bf72-a3a0d2814ab1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEEDFIX
• Version Model Number: OM-7555
• Catalog Number: OM-7555
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM
• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM
• Phone: +1(978)269-4663
• Email: ROBERT.GUZMAN@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817470012118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101437

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2015-10-08

On-Brand Devices [SPEEDFIX]

• 00817470012125: SPEEDFIX ULTRA KIT 70X8.6MM
• 00817470012118: SPEEDFIX ULTRA KIT 55X8.2MM
• 00817470000900: SPEEDFIX IMPLANT