ActivaScrew™ B-AL-3540

GUDID E302BAL35409

ActivaScrew™ LAG 3.5 x 40 mm, thread 14 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: E302BAL35409
• NIH Device Record Key: 89cd5ae1-64f4-4903-bc3a-ffca3ad77ce9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActivaScrew™
• Version Model Number: B-AL-3540
• Catalog Number: B-AL-3540
• 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

• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0
• Width: 3.5 Millimeter
• Length: 40 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BAL35409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081392

FDA Product Code

• HWC: Screw, Fixation, Bone

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™]

• E302BASC45909: ActivaScrew™ Cannulated 4.5 x 90 mm
• E302BASC45809: ActivaScrew™ Cannulated 4.5 x 80 mm
• E302BASC45709: ActivaScrew™ Cannulated 4.5 x 70 mm
• E302BASC45659: ActivaScrew™ Cannulated 4.5 x 65 mm
• E302BASC45609: ActivaScrew™ Cannulated 4.5 x 60 mm
• E302BASC45559: ActivaScrew™ Cannulated 4.5 x 55 mm
• E302BASC45509: ActivaScrew™ Cannulated 4.5 x 50 mm
• E302BASC45459: ActivaScrew™ Cannulated 4.5 x 45 mm
• E302BASC45409: ActivaScrew™ Cannulated 4.5 x 40 mm
• E302BASC45359: ActivaScrew™ Cannulated 4.5 x 35 mm
• E302BASC45309: ActivaScrew™ Cannulated 4.5 x 30 mm
• E302BASC45259: ActivaScrew™ Cannulated 4.5 x 25 mm
• E302BASC40909: ActivaScrew™ Cannulated 4.0 x 90 mm
• E302BASC40809: ActivaScrew™ Cannulated 4.0 x 80 mm
• E302BASC40709: ActivaScrew™ Cannulated 4.0 x 70 mm
• E302BASC40659: ActivaScrew™ Cannulated 4.0 x 65 mm
• E302BASC40609: ActivaScrew™ Cannulated 4.0 x 60 mm
• E302BASC40559: ActivaScrew™ Cannulated 4.0 x 55 mm
• E302BASC40509: ActivaScrew™ Cannulated 4.0 x 50 mm
• E302BASC40459: ActivaScrew™ Cannulated 4.0 x 45 mm
• E302BASC40409: ActivaScrew™ Cannulated 4.0 x 40 mm
• E302BASC40359: ActivaScrew™ Cannulated 4.0 x 35 mm
• E302BASC40309: ActivaScrew™ Cannulated 4.0 x 30 mm
• E302BASC35409: ActivaScrew™ Cannulated 3.5 x 40 mm
• E302BASC35369: ActivaScrew™ Cannulated 3.5 x 36 mm
• E302BASC35329: ActivaScrew™ Cannulated 3.5 x 32 mm
• E302BASC35289: ActivaScrew™ Cannulated 3.5 x 28 mm
• E302BASC35249: ActivaScrew™ Cannulated 3.5 x 24 mm
• E302BASC35209: ActivaScrew™ Cannulated 3.5 x 20 mm
• E302BAS45909: ActivaScrew™ 4.5 x 90 mm
• E302BAS45709: ActivaScrew™ 4.5 x 70 mm
• E302BAS45659: ActivaScrew™ 4.5 x 65 mm
• E302BAS45609: ActivaScrew™ 4.5 x 60 mm
• E302BAS45559: ActivaScrew™ 4.5 x 55 mm
• E302BAS45509: ActivaScrew™ 4.5 x 50 mm
• E302BAS45459: ActivaScrew™ 4.5 x 45 mm
• E302BAS45409: ActivaScrew™ 4.5 x 40 mm
• E302BAS45359: ActivaScrew™ 4.5 x 35 mm
• E302BAS45309: ActivaScrew™ 4.5 x 30 mm
• E302BAS45259: ActivaScrew™ 4.5 x 25 mm
• E302BAS35509: ActivaScrew™ 3.5 x 50 mm
• E302BAS35409: ActivaScrew™ 3.5 x 40 mm
• E302BAS35369: ActivaScrew™ 3.5 x 36 mm
• E302BAS35329: ActivaScrew™ 3.5 x 32 mm
• E302BAS35289: ActivaScrew™ 3.5 x 28 mm
• E302BAS35249: ActivaScrew™ 3.5 x 24 mm
• E302BAS35209: ActivaScrew™ 3.5 x 20 mm
• E302BAS35169: ActivaScrew™ 3.5 x 16 mm
• E302BAS27249: ActivaScrew™ 2.7 x 24 mm
• E302BAS27209: ActivaScrew™ 2.7 x 20 mm