GEO Hammertoe Screw

GUDID B471150020130

Hammertoe Screw 2.0x13 Solid 0 Deg. Ti

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: B471150020130
• NIH Device Record Key: 8aecc413-a082-40cb-9fc0-b6957a22bc82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEO Hammertoe Screw
• Version Model Number: 15002013
• Company DUNS: 080068420
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC
• 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: false
• Serial Number: true
• 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: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho

Device Dimensions

• Outer Diameter: 2 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 13 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471150020130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170571

FDA Product Code

• HWC: Screw, fixation, bone

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: 2018-11-12
• Device Publish Date: 2018-10-10

On-Brand Devices [GEO Hammertoe Screw]

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• B471150230130: Hammertoe Screw 3.0x13 Cannulated 0 Deg. Ti
• B471150225150: Hammertoe Screw 2.5x15 Cannulated 0 Deg. Ti
• B471150225130: Hammertoe Screw 2.5x13 Cannulated 0 Deg. Ti
• B471150220150: Hammertoe Screw 2.0x15 Cannulated 0 Deg. Ti
• B471150220130: Hammertoe Screw 2.0x13 Cannulated 0 Deg. Ti
• B471150130150: Hammertoe Screw 3.0x15 Solid 10 Deg. Ti
• B471150130130: Hammertoe Screw 3.0x13 Solid 10 Deg. Ti
• B471150125150: Hammertoe Screw 2.5x15 Solid 10 Deg. Ti
• B471150125130: Hammertoe Screw 2.5x13 Solid 10 Deg. Ti
• B471150120150: Hammertoe Screw 2.0x15 Solid 10 Deg. Ti
• B471150120130: Hammertoe Screw 2.0x13 Solid 10 Deg. Ti
• B471150030150: Hammertoe Screw 3.0x15 Solid 0 Deg. Ti
• B471150030130: Hammertoe Screw 3.0x13 Solid 0 Deg. Ti
• B471150025150: Hammertoe Screw 2.5x15 Solid 0 Deg. Ti
• B471150025130: Hammertoe Screw 2.5x13 Solid 0 Deg. Ti
• B471150020150: Hammertoe Screw 2.0x15 Solid 0 Deg. Ti
• B471150020130: Hammertoe Screw 2.0x13 Solid 0 Deg. Ti