RFS™ Screw RFS-C4055L

GUDID E302RFSC4055L9

RFS™ Screw Cannulated LAG 4.0 x 55 mm, thread 26 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: E302RFSC4055L9
• NIH Device Record Key: d9651a4a-6b3c-4c22-8b9b-8a08220f5510
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RFS™ Screw
• Version Model Number: RFS-C4055L
• Catalog Number: RFS-C4055L
• 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
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0
• Length: 55 Millimeter
• Width: 4 Millimeter
• Device Size Text, specify: 0

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	E302RFSC4055L9 [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: 2015-09-23

On-Brand Devices [RFS™ Screw]

• E302RFSS45909: RFS™ Screw 4.5 x 90 mm
• E302RFSS4550L9: RFS™ Screw LAG 4.5 x 50 mm, thread 24 mm
• E302RFSS45509: RFS™ Screw 4.5 x 50 mm
• E302RFSS4545L9: RFS™ Screw LAG 4.5 x 45 mm, thread 22 mm
• E302RFSS45459: RFS™ Screw 4.5 x 45 mm
• E302RFSS4540L9: RFS™ Screw LAG 4.5 x 40 mm, thread 20 mm
• E302RFSS45409: RFS™ Screw 4.5 x 40 mm
• E302RFSS4535L9: RFS™ Screw LAG 4.5 x 35 mm, thread 18 mm
• E302RFSS45359: RFS™ Screw 4.5 x 35 mm
• E302RFSS3545L9: RFS™ Screw LAG 3.5 x 45 mm, thread 15 mm
• E302RFSS3540L9: RFS™ Screw LAG 3.5 x 40 mm, thread 14 mm
• E302RFSS35409: RFS™ Screw 3.5 x 40 mm
• E302RFSS35369: RFS™ Screw 3.5 x 36 mm
• E302RFSS35329: RFS™ Screw 3.5 x 32 mm
• E302RFSS3530L9: RFS™ Screw LAG 3.5 x 30 mm, thread 14 mm
• E302RFSS35289: RFS™ Screw 3.5 x 28 mm
• E302RFSS35249: RFS™ Screw 3.5 x 24 mm
• E302RFSS3520L9: RFS™ Screw LAG 3.5 x 20 mm, thread 8 mm
• E302RFSS35209: RFS™ Screw 3.5 x 20 mm
• E302RFSS35169: RFS™ Screw 3.5 x 16 mm
• E302RFSS35149: RFS™ Screw 3.5 x 14 mm
• E302RFSS27249: RFS™ Screw 2.7 x 24 mm
• E302RFSS27209: RFS™ Screw 2.7 x 20 mm
• E302RFSS27189: RFS™ Screw 2.7 x 18 mm
• E302RFSS27169: RFS™ Screw 2.7 x 16 mm
• E302RFSS27149: RFS™ Screw 2.7 x 14 mm
• E302RFSS27129: RFS™ Screw 2.7 x 12 mm
• E302RFSC4590L9: RFS™ Screw Cannulated LAG 4.5 x 90 mm, thread 46 mm
• E302RFSC45909: RFS™ Screw Cannulated 4.5 x 90 mm
• E302RFSC4580L9: RFS™ Screw Cannulated LAG 4.5 x 80 mm, thread 40 mm
• E302RFSC45809: RFS™ Screw Cannulated 4.5 x 80 mm
• E302RFSC4570L9: RFS™ Screw Cannulated LAG 4.5 x 70 mm, thread 32 mm
• E302RFSC45709: RFS™ Screw Cannulated 4.5 x 70 mm
• E302RFSC4565L9: RFS™ Screw Cannulated LAG 4.5 x 65 mm, thread 30 mm
• E302RFSC4560L9: RFS™ Screw Cannulated LAG 4.5 x 60 mm, thread 28 mm
• E302RFSC45609: RFS™ Screw Cannulated 4.5 x 60 mm
• E302RFSC4555L9: RFS™ Screw Cannulated LAG 4.5 x 55 mm, thread 26 mm
• E302RFSC4550L9: RFS™ Screw Cannulated LAG 4.5 x 50 mm, thread 24 mm
• E302RFSC45509: RFS™ Screw Cannulated 4.5 x 50 mm
• E302RFSC4545L9: RFS™ Screw Cannulated LAG 4.5 x 45 mm, thread 22 mm
• E302RFSC4540L9: RFS™ Screw Cannulated LAG 4.5 x 40 mm, thread 20 mm
• E302RFSC45409: RFS™ Screw Cannulated 4.5 x 40 mm
• E302RFSC4090L9: RFS™ Screw Cannulated LAG 4.0 x 90 mm, thread 46 mm
• E302RFSC40909: RFS™ Screw Cannulated 4.0 x 90 mm
• E302RFSC4080L9: RFS™ Screw Cannulated LAG 4.0 x 80 mm, thread 40 mm
• E302RFSC40809: RFS™ Screw Cannulated 4.0 x 80 mm
• E302RFSC4070L9: RFS™ Screw Cannulated LAG 4.0 x 70 mm, thread 32 mm
• E302RFSC40709: RFS™ Screw Cannulated 4.0 x 70 mm
• E302RFSC4065L9: RFS™ Screw Cannulated LAG 4.0 x 65 mm, thread 30 mm
• E302RFSC40659: RFS™ Screw Cannulated 4.0 x 65 mm