ActivaScrew™ B-ALC-4030

GUDID E302BALC40309

ActivaScrew™ Cannulated LAG 4.0x30 mm, thread 15 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable
Primary Device IDE302BALC40309
NIH Device Record Key197a674d-81cc-403d-89ee-e97803a5d461
Commercial Distribution StatusIn Commercial Distribution
Brand NameActivaScrew™
Version Model NumberB-ALC-4030
Catalog NumberB-ALC-4030
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

Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter
Device Size Text, specify0
Length30 Millimeter
Width4 Millimeter

Operating and Storage Conditions

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
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE302BALC40309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

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 Date2015-08-21

On-Brand Devices [ActivaScrew™]

E302BASC45909ActivaScrew™ Cannulated 4.5 x 90 mm
E302BASC45809ActivaScrew™ Cannulated 4.5 x 80 mm
E302BASC45709ActivaScrew™ Cannulated 4.5 x 70 mm
E302BASC45659ActivaScrew™ Cannulated 4.5 x 65 mm
E302BASC45609ActivaScrew™ Cannulated 4.5 x 60 mm
E302BASC45559ActivaScrew™ Cannulated 4.5 x 55 mm
E302BASC45509ActivaScrew™ Cannulated 4.5 x 50 mm
E302BASC45459ActivaScrew™ Cannulated 4.5 x 45 mm
E302BASC45409ActivaScrew™ Cannulated 4.5 x 40 mm
E302BASC45359ActivaScrew™ Cannulated 4.5 x 35 mm
E302BASC45309ActivaScrew™ Cannulated 4.5 x 30 mm
E302BASC45259ActivaScrew™ Cannulated 4.5 x 25 mm
E302BASC40909ActivaScrew™ Cannulated 4.0 x 90 mm
E302BASC40809ActivaScrew™ Cannulated 4.0 x 80 mm
E302BASC40709ActivaScrew™ Cannulated 4.0 x 70 mm
E302BASC40659ActivaScrew™ Cannulated 4.0 x 65 mm
E302BASC40609ActivaScrew™ Cannulated 4.0 x 60 mm
E302BASC40559ActivaScrew™ Cannulated 4.0 x 55 mm
E302BASC40509ActivaScrew™ Cannulated 4.0 x 50 mm
E302BASC40459ActivaScrew™ Cannulated 4.0 x 45 mm
E302BASC40409ActivaScrew™ Cannulated 4.0 x 40 mm
E302BASC40359ActivaScrew™ Cannulated 4.0 x 35 mm
E302BASC40309ActivaScrew™ Cannulated 4.0 x 30 mm
E302BASC35409ActivaScrew™ Cannulated 3.5 x 40 mm
E302BASC35369ActivaScrew™ Cannulated 3.5 x 36 mm
E302BASC35329ActivaScrew™ Cannulated 3.5 x 32 mm
E302BASC35289ActivaScrew™ Cannulated 3.5 x 28 mm
E302BASC35249ActivaScrew™ Cannulated 3.5 x 24 mm
E302BASC35209ActivaScrew™ Cannulated 3.5 x 20 mm
E302BAS45909ActivaScrew™ 4.5 x 90 mm
E302BAS45709ActivaScrew™ 4.5 x 70 mm
E302BAS45659ActivaScrew™ 4.5 x 65 mm
E302BAS45609ActivaScrew™ 4.5 x 60 mm
E302BAS45559ActivaScrew™ 4.5 x 55 mm
E302BAS45509ActivaScrew™ 4.5 x 50 mm
E302BAS45459ActivaScrew™ 4.5 x 45 mm
E302BAS45409ActivaScrew™ 4.5 x 40 mm
E302BAS45359ActivaScrew™ 4.5 x 35 mm
E302BAS45309ActivaScrew™ 4.5 x 30 mm
E302BAS45259ActivaScrew™ 4.5 x 25 mm
E302BAS35509ActivaScrew™ 3.5 x 50 mm
E302BAS35409ActivaScrew™ 3.5 x 40 mm
E302BAS35369ActivaScrew™ 3.5 x 36 mm
E302BAS35329ActivaScrew™ 3.5 x 32 mm
E302BAS35289ActivaScrew™ 3.5 x 28 mm
E302BAS35249ActivaScrew™ 3.5 x 24 mm
E302BAS35209ActivaScrew™ 3.5 x 20 mm
E302BAS35169ActivaScrew™ 3.5 x 16 mm
E302BAS27249ActivaScrew™ 2.7 x 24 mm
E302BAS27209ActivaScrew™ 2.7 x 20 mm

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