RFS™ Screw RFS-C4050L

GUDID E302RFSC4050L9

RFS™ Screw Cannulated LAG 4.0 x 50 mm, thread 24 mm

Bioretec Oy

Orthopaedic bone screw, bioabsorbable
Primary Device IDE302RFSC4050L9
NIH Device Record Key6151f4f3-bb8b-4752-8a1d-b7b004a322b0
Commercial Distribution Discontinuation2017-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRFS™ Screw
Version Model NumberRFS-C4050L
Catalog NumberRFS-C4050L
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

Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 Millimeter
Device Size Text, specify0
Width4 Millimeter
Length50 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
HIBCCE302RFSC4050L9 [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 Date2015-09-23

On-Brand Devices [RFS™ Screw]

E302RFSS45909RFS™ Screw 4.5 x 90 mm
E302RFSS4550L9RFS™ Screw LAG 4.5 x 50 mm, thread 24 mm
E302RFSS45509RFS™ Screw 4.5 x 50 mm
E302RFSS4545L9RFS™ Screw LAG 4.5 x 45 mm, thread 22 mm
E302RFSS45459RFS™ Screw 4.5 x 45 mm
E302RFSS4540L9RFS™ Screw LAG 4.5 x 40 mm, thread 20 mm
E302RFSS45409RFS™ Screw 4.5 x 40 mm
E302RFSS4535L9RFS™ Screw LAG 4.5 x 35 mm, thread 18 mm
E302RFSS45359RFS™ Screw 4.5 x 35 mm
E302RFSS3545L9RFS™ Screw LAG 3.5 x 45 mm, thread 15 mm
E302RFSS3540L9RFS™ Screw LAG 3.5 x 40 mm, thread 14 mm
E302RFSS35409RFS™ Screw 3.5 x 40 mm
E302RFSS35369RFS™ Screw 3.5 x 36 mm
E302RFSS35329RFS™ Screw 3.5 x 32 mm
E302RFSS3530L9RFS™ Screw LAG 3.5 x 30 mm, thread 14 mm
E302RFSS35289RFS™ Screw 3.5 x 28 mm
E302RFSS35249RFS™ Screw 3.5 x 24 mm
E302RFSS3520L9RFS™ Screw LAG 3.5 x 20 mm, thread 8 mm
E302RFSS35209RFS™ Screw 3.5 x 20 mm
E302RFSS35169RFS™ Screw 3.5 x 16 mm
E302RFSS35149RFS™ Screw 3.5 x 14 mm
E302RFSS27249RFS™ Screw 2.7 x 24 mm
E302RFSS27209RFS™ Screw 2.7 x 20 mm
E302RFSS27189RFS™ Screw 2.7 x 18 mm
E302RFSS27169RFS™ Screw 2.7 x 16 mm
E302RFSS27149RFS™ Screw 2.7 x 14 mm
E302RFSS27129RFS™ Screw 2.7 x 12 mm
E302RFSC4590L9RFS™ Screw Cannulated LAG 4.5 x 90 mm, thread 46 mm
E302RFSC45909RFS™ Screw Cannulated 4.5 x 90 mm
E302RFSC4580L9RFS™ Screw Cannulated LAG 4.5 x 80 mm, thread 40 mm
E302RFSC45809RFS™ Screw Cannulated 4.5 x 80 mm
E302RFSC4570L9RFS™ Screw Cannulated LAG 4.5 x 70 mm, thread 32 mm
E302RFSC45709RFS™ Screw Cannulated 4.5 x 70 mm
E302RFSC4565L9RFS™ Screw Cannulated LAG 4.5 x 65 mm, thread 30 mm
E302RFSC4560L9RFS™ Screw Cannulated LAG 4.5 x 60 mm, thread 28 mm
E302RFSC45609RFS™ Screw Cannulated 4.5 x 60 mm
E302RFSC4555L9RFS™ Screw Cannulated LAG 4.5 x 55 mm, thread 26 mm
E302RFSC4550L9RFS™ Screw Cannulated LAG 4.5 x 50 mm, thread 24 mm
E302RFSC45509RFS™ Screw Cannulated 4.5 x 50 mm
E302RFSC4545L9RFS™ Screw Cannulated LAG 4.5 x 45 mm, thread 22 mm
E302RFSC4540L9RFS™ Screw Cannulated LAG 4.5 x 40 mm, thread 20 mm
E302RFSC45409RFS™ Screw Cannulated 4.5 x 40 mm
E302RFSC4090L9RFS™ Screw Cannulated LAG 4.0 x 90 mm, thread 46 mm
E302RFSC40909RFS™ Screw Cannulated 4.0 x 90 mm
E302RFSC4080L9RFS™ Screw Cannulated LAG 4.0 x 80 mm, thread 40 mm
E302RFSC40809RFS™ Screw Cannulated 4.0 x 80 mm
E302RFSC4070L9RFS™ Screw Cannulated LAG 4.0 x 70 mm, thread 32 mm
E302RFSC40709RFS™ Screw Cannulated 4.0 x 70 mm
E302RFSC4065L9RFS™ Screw Cannulated LAG 4.0 x 65 mm, thread 30 mm
E302RFSC40659RFS™ Screw Cannulated 4.0 x 65 mm

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