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)
• M6954014531000: Headless Ø4.5 x 100mm Long Thread Ti (Torx)
• M695401452200: Headless Ø4.5 x 20mm Short Thread Ti (Torx)
• M6954014521100: Headless Ø4.5 x 110mm Short Thread Ti (Torx)
• M6954014521000: Headless Ø4.5 x 100mm Short Thread Ti (Torx)
• M695401304400: Headless Ø3.0 x 40mm Full Thread Ti (Torx)
• M695401304330: Headless Ø3.0 x 33mm Full Thread Ti (Torx)
• M695401304320: Headless Ø3.0 x 32mm Full Thread Ti (Torx)
• M695401304310: Headless Ø3.0 x 31mm Full Thread Ti (Torx)
• M695401304300: Headless Ø3.0 x 30mm Full Thread Ti (Torx)
• M695401304240: Headless Ø3.0 x 24mm Full Thread Ti (Torx)
• M695401304230: Headless Ø3.0 x 23mm Full Thread Ti (Torx)
• M695401304220: Headless Ø3.0 x 22mm Full Thread Ti (Torx)
• M695401304210: Headless Ø3.0 x 21mm Full Thread Ti (Torx)
• M695401304200: Headless Ø3.0 x 20mm Full Thread Ti (Torx)
• M695401304150: Headless Ø3.0 x 15mm Full Thread Ti (Torx)
• M695401304140: Headless Ø3.0 x 14mm Full Thread Ti (Torx)
• M695401304130: Headless Ø3.0 x 13mm Full Thread Ti (Torx)
• M695401304120: Headless Ø3.0 x 12mm Full Thread Ti (Torx)
• M695401304110: Headless Ø3.0 x 11mm Full Thread Ti (Torx)
• M695401304100: Headless Ø3.0 x 10mm Full Thread Ti (Torx)
• M695401303400: Headless Ø3.0 x 40mm Long Thread Ti (Torx)
• M695401303340: Headless Ø3.0 x 34mm Long Thread Ti (Torx)
• M695401303330: Headless Ø3.0 x 33mm Long Thread Ti (Torx)
• M695401303320: Headless Ø3.0 x 32mm Long Thread Ti (Torx)
• M695401303310: Headless Ø3.0 x 31mm Long Thread Ti (Torx)
• M695401303300: Headless Ø3.0 x 30mm Long Thread Ti (Torx)
• M695401303250: Headless Ø3.0 x 25mm Long Thread Ti (Torx)
• M695401303240: Headless Ø3.0 x 24mm Long Thread Ti (Torx)
• M695401303230: Headless Ø3.0 x 23mm Long Thread Ti (Torx)
• M695401303220: Headless Ø3.0 x 22mm Long Thread Ti (Torx)
• M695401303210: Headless Ø3.0 x 21mm Long Thread Ti (Torx)
• M695401303200: Headless Ø3.0 x 20mm Long Thread Ti (Torx)