ActivaScrew™ Interference B-AI-0928

GUDID E302BAI09289

ActivaScrew™ Interference 9 x 28 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable
Primary Device IDE302BAI09289
NIH Device Record Key6a0a94bb-6114-4cd9-8c3c-ddc6f557ba81
Commercial Distribution StatusIn Commercial Distribution
Brand NameActivaScrew™ Interference
Version Model NumberB-AI-0928
Catalog NumberB-AI-0928
Company DUNS368715301
Company NameBioretec Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com
Phone+358207789500
Emailsales@bioretec.com

Device Dimensions

Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter
Width9 Millimeter
Length28 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE302BAI09289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-20

On-Brand Devices [ActivaScrew™ Interference]

E302BAI10339ActivaScrew™ Interference 10 x 33 mm
E302BAI10309ActivaScrew™ Interference 10 x 30 mm
E302BAI10289ActivaScrew™ Interference 10 x 28 mm
E302BAI10249ActivaScrew™ Interference 10 x 24 mm
E302BAI09339ActivaScrew™ Interference 9 x 33 mm
E302BAI09309ActivaScrew™ Interference 9 x 30 mm
E302BAI09289ActivaScrew™ Interference 9 x 28 mm
E302BAI09249ActivaScrew™ Interference 9 x 24 mm
E302BAI09209ActivaScrew™ Interference 9 x 20 mm
E302BAI08339ActivaScrew™ Interference 8 x 33 mm
E302BAI08309ActivaScrew™ Interference 8 x 30 mm
E302BAI08289ActivaScrew™ Interference 8 x 28 mm
E302BAI08249ActivaScrew™ Interference 8 x 24 mm
E302BAI08209ActivaScrew™ Interference 8 x 20 mm
E302BAI07309ActivaScrew™ Interference 7 x 30 mm
E302BAI07269ActivaScrew™ Interference 7 x 26 mm
E302BAI07249ActivaScrew™ Interference 7 x 24 mm
E302BAI07209ActivaScrew™ Interference 7 x 20 mm
E302BAI06269ActivaScrew™ Interference 6 x 26 mm
E302BAI06209ActivaScrew™ Interference 6 x 20 mm
E302BAI06159ActivaScrew™ Interference 6 x 15 mm
E302BAI05209ActivaScrew™ Interference 5 x 20 mm
E302BAI05159ActivaScrew™ Interference 5 x 15 mm
E302BAI05109ActivaScrew™ Interference 5 x 10 mm
E302BAI04209ActivaScrew™ Interference 4 x 20 mm
E302BAI04159ActivaScrew™ Interference 4 x 15 mm
E302BAI04109ActivaScrew™ Interference 4 x 10 mm

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