Headless Screw System 401-25216

GUDID M695401252160

Ø2.5 x 16mm Short Thread Ti (Torx)

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M695401252160
• NIH Device Record Key: 0791af04-6380-465b-bf95-0eca35e1672c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headless Screw System
• Version Model Number: 401-25216
• Catalog Number: 401-25216
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695401252160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133842

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

[M695401252160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-03

On-Brand Devices [Headless Screw System]

• M695401252220: Ø2.5 x 22mm Short Thread Ti (Torx)
• M695401252200: Ø2.5 x 20mm Short Thread Ti (Torx)
• M695401252180: Ø2.5 x 18mm Short Thread Ti (Torx)
• M695401252160: Ø2.5 x 16mm Short Thread Ti (Torx)
• M695401252140: Ø2.5 x 14mm Short Thread Ti (Torx)