SF Push-in Anchor 3.0 B04-421

GUDID 07649990202235

Surgical Fusion Technologies GmbH

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 07649990202235
• NIH Device Record Key: 2a8f6100-3df2-4ad4-b34d-2a27f01d3641
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SF Push-in Anchor 3.0
• Version Model Number: SF Push-in Anchor 3.0
• Catalog Number: B04-421
• Company DUNS: 482948937
• Company Name: Surgical Fusion Technologies GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com
• Phone: +41442046018
• Email: complaints@surgical-fusion.com

Device Dimensions

• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter
• Width: 3 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius
• Special Storage Condition, Specify: Between 0 and 0 *max.43.3 Celcius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649990202235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240288

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2024-04-22
• Device Publish Date: 2024-04-12

Devices Manufactured by Surgical Fusion Technologies GmbH

• 07649990202419 - Drill S-PI-A1.6 extra short: 2026-01-26 Drill extra short for SF Push-in Anchor 1.6
• 07649990202020 - Tray_SF Push-In Anchor 2.3: 2024-11-29 Tray SF Push-in Anchor 2.3
• 07649990202075 - SupraFuser Generator: 2024-04-22
• 07649990202228 - SF Push-in Anchor 1.6: 2024-04-22
• 07649990202235 - SF Push-in Anchor 3.0: 2024-04-22
• 07649990202235 - SF Push-in Anchor 3.0: 2024-04-22
• 07649990202259 - Stopper S-PI-A1.6: 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 1.6
• 07649990202266 - Stopper S-PI-A2.3: 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 2.3
• 07649990202273 - Stopper S-PI-A3.0: 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 3.0