ComposiTCP 110004604

GUDID 03760154006750

Absorbable interference screw

S.B.M

Orthopaedic bone screw, bioabsorbable
Primary Device ID03760154006750
NIH Device Record Key06a3d4fc-afb9-4446-8a0a-824c685de902
Commercial Distribution StatusIn Commercial Distribution
Brand NameComposiTCP
Version Model NumberComposiTCP 30 round head
Catalog Number110004604
Company DUNS772462123
Company NameS.B.M
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

Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com
Phone574-371-1176
Emailelizabeth.wray@zimmerbiomet.com

Device Dimensions

Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter
Outer Diameter7 Millimeter
Length20 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154006750 [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 Number4
Public Version Date2022-07-14
Device Publish Date2015-09-23

On-Brand Devices [ComposiTCP]

03760154007207Absorbable interference screw
03760154007191Absorbable interference screw
03760154007184Absorbable interference screw
03760154007177Absorbable interference screw
03760154007160Absorbable interference screw
03760154007153Absorbable interference screw
03760154007047Absorbable interference screw
03760154007030Absorbable interference screw
03760154007023Absorbable interference screw
03760154007016Absorbable interference screw
03760154006996Absorbable interference screw
03760154006989Absorbable interference screw
03760154006972Absorbable interference screw
03760154006965Absorbable interference screw
03760154006958Absorbable interference screw
03760154006941Absorbable interference screw
03760154006934Absorbable interference screw
03760154006927Absorbable interference screw
03760154006910Absorbable interference screw
03760154006903Absorbable interference screw
03760154006897Absorbable interference screw
03760154006880Absorbable interference screw
03760154006873Absorbable interference screw
03760154006866Absorbable interference screw
03760154006859Absorbable interference screw
03760154006842Absorbable interference screw
03760154006835Absorbable interference screw
03760154006828Absorbable interference screw
03760154006811Absorbable interference screw
03760154006804Absorbable interference screw
03760154006798Absorbable interference screw
03760154006781Absorbable interference screw
03760154006774Absorbable interference screw
03760154006767Absorbable interference screw
03760154006750Absorbable interference screw
03760154006743Absorbable interference screw
03760154006736Absorbable interference screw
03760154006729Absorbable interference screw
03760154006712Absorbable interference screw
03760154006705Absorbable interference screw
03760154006699Absorbable interference screw
03760154006682Absorbable interference screw
03760154006675Absorbable interference screw
03760154006668Absorbable interference screw
03760154006651Absorbable interference screw
03760154006644Absorbable interference screw
03760154006637Absorbable interference screw
03760154006620Absorbable interference screw
03760154006613Absorbable interference screw
03760154006606Absorbable interference screw

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