ActivaScrew™ B-ALC-4035

GUDID E302BALC40359

ActivaScrew™ Cannulated LAG 4.0x35 mm, thread 18 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable
Primary Device IDE302BALC40359
NIH Device Record Keycbe54fff-9437-4a44-8ceb-ba9e4bbe6636
Commercial Distribution StatusIn Commercial Distribution
Brand NameActivaScrew™
Version Model NumberB-ALC-4035
Catalog NumberB-ALC-4035
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

Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length35 Millimeter
Device Size Text, specify0

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
HIBCCE302BALC40359 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.