TorqLoc Interference 10-1009-0830

GUDID E30210100908309

TorqLoc Interference 8 x 30 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: E30210100908309
• NIH Device Record Key: 56f9f502-a5ff-4214-ad08-51af6ab5776c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TorqLoc Interference
• Version Model Number: 10-1009-0830
• Catalog Number: 10-1009-0830
• 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
• 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

• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter
• Width: 8 Millimeter
• Length: 30 Millimeter

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
• 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	E30210100908309 [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: 2017-02-15

On-Brand Devices [TorqLoc Interference]

• E30210100910339: TorqLoc Interference 10 x 33 mm
• E30210100910309: TorqLoc Interference 10 x 30 mm
• E30210100910289: TorqLoc Interference 10 x 28 mm
• E30210100910249: TorqLoc Interference 10 x 24 mm
• E30210100909339: TorqLoc Interference 9 x 33 mm
• E30210100909309: TorqLoc Interference 9 x 30 mm
• E30210100909289: TorqLoc Interference 9 x 28 mm
• E30210100909249: TorqLoc Interference 9 x 24 mm
• E30210100909209: TorqLoc Interference 9 x 20 mm
• E30210100908339: TorqLoc Interference 8 x 33 mm
• E30210100908309: TorqLoc Interference 8 x 30 mm
• E30210100908289: TorqLoc Interference 8 x 28 mm
• E30210100908249: TorqLoc Interference 8 x 24 mm
• E30210100908209: TorqLoc Interference 8 x 20 mm
• E30210100907309: TorqLoc Interference 7 x 30 mm
• E30210100907269: TorqLoc Interference 7 x 26 mm
• E30210100907249: TorqLoc Interference 7 x 24 mm
• E30210100907209: TorqLoc Interference 7 x 20 mm
• E30210100906269: TorqLoc Interference 6 x 26 mm
• E30210100906209: TorqLoc Interference 6 x 20 mm
• E30210100906159: TorqLoc Interference 6 x 15 mm
• E30210100905209: TorqLoc Interference 5 x 20 mm
• E30210100905159: TorqLoc Interference 5 x 15 mm
• E30210100905109: TorqLoc Interference 5 x 10 mm
• E30210100904209: TorqLoc Interference 4 x 20 mm
• E30210100904159: TorqLoc Interference 4 x 15 mm
• E30210100904109: TorqLoc Interference 4 x 10 mm