ActivaScrew™ Interference B-AI-0415

GUDID E302BAI04159

ActivaScrew™ Interference 4 x 15 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: E302BAI04159
• NIH Device Record Key: d92e442e-e567-4f59-8111-58586dab6b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaScrew™ Interference
• Version Model Number: B-AI-0415
• Catalog Number: B-AI-0415
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• 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: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com

Device Dimensions

• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter
• Length: 15 Millimeter
• Width: 4 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BAI04159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130716

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-20

On-Brand Devices [ActivaScrew™ Interference]

• E302BAI10339: ActivaScrew™ Interference 10 x 33 mm
• E302BAI10309: ActivaScrew™ Interference 10 x 30 mm
• E302BAI10289: ActivaScrew™ Interference 10 x 28 mm
• E302BAI10249: ActivaScrew™ Interference 10 x 24 mm
• E302BAI09339: ActivaScrew™ Interference 9 x 33 mm
• E302BAI09309: ActivaScrew™ Interference 9 x 30 mm
• E302BAI09289: ActivaScrew™ Interference 9 x 28 mm
• E302BAI09249: ActivaScrew™ Interference 9 x 24 mm
• E302BAI09209: ActivaScrew™ Interference 9 x 20 mm
• E302BAI08339: ActivaScrew™ Interference 8 x 33 mm
• E302BAI08309: ActivaScrew™ Interference 8 x 30 mm
• E302BAI08289: ActivaScrew™ Interference 8 x 28 mm
• E302BAI08249: ActivaScrew™ Interference 8 x 24 mm
• E302BAI08209: ActivaScrew™ Interference 8 x 20 mm
• E302BAI07309: ActivaScrew™ Interference 7 x 30 mm
• E302BAI07269: ActivaScrew™ Interference 7 x 26 mm
• E302BAI07249: ActivaScrew™ Interference 7 x 24 mm
• E302BAI07209: ActivaScrew™ Interference 7 x 20 mm
• E302BAI06269: ActivaScrew™ Interference 6 x 26 mm
• E302BAI06209: ActivaScrew™ Interference 6 x 20 mm
• E302BAI06159: ActivaScrew™ Interference 6 x 15 mm
• E302BAI05209: ActivaScrew™ Interference 5 x 20 mm
• E302BAI05159: ActivaScrew™ Interference 5 x 15 mm
• E302BAI05109: ActivaScrew™ Interference 5 x 10 mm
• E302BAI04209: ActivaScrew™ Interference 4 x 20 mm
• E302BAI04159: ActivaScrew™ Interference 4 x 15 mm
• E302BAI04109: ActivaScrew™ Interference 4 x 10 mm