ActivaScrew™ Interference B-AI-1028

GUDID E302BAI10289

ActivaScrew™ Interference 10 x 28 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable

Primary Device ID	E302BAI10289
NIH Device Record Key	382ed879-d9f6-4d08-8be8-0bcb94ae46c7
Commercial Distribution Status	In Commercial Distribution
Brand Name	ActivaScrew™ Interference
Version Model Number	B-AI-1028
Catalog Number	B-AI-1028
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

Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 Millimeter
Width	10 Millimeter
Length	28 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BAI10289 [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