Biosteon® Screw 234-010-170

GUDID 15060155711239

The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-latic) Acid and calcium phosphate which will be gradually r

BIOCOMPOSITES LTD

Orthopaedic bone screw, bioabsorbable
Primary Device ID15060155711239
NIH Device Record Key075ed0d8-dbd2-48de-aa6e-96a1f5a9f096
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiosteon® Screw
Version Model Number234-010-170
Catalog Number234-010-170
Company DUNS424382307
Company NameBIOCOMPOSITES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com

Device Dimensions

Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter
Length23 Millimeter
Width10 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 117 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 47 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115060155711239 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2015-07-24

On-Brand Devices [Biosteon® Screw]

15060155711260The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155711253The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155711246The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati
15060155711239The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati
15060155711222The Biosteon® ACL Screw is a cannulated, single-use bone screw made of a resorbable Poly (L-lac
15060155710348The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710331The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710324The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710317The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710300The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710294The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710287The Biosteon® ACL Screw is a cannulated single-use bone screw made of a resorbable Poly (l-lact
15060155710270The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati
15060155710263The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati
15060155710256The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati
15060155710249The Biosteon® ACL screw is a cannulated single-use bone screw made of a resorbable Poly (L-lati

Trademark Results [Biosteon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSTEON
BIOSTEON
76266609 2648714 Live/Registered
Biocomposites Ltd
2001-06-04

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