447116

GUDID 10887587052922

2.0MM TI SAGITTAL SPLIT PLATE WITH ADJUSTABLE SLIDER - 40MM

SYNTHES (U.S.A.) LP

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device ID10887587052922
NIH Device Record Keydfb6262f-5cb1-434e-94e0-c1afb666b2ad
Commercial Distribution StatusIn Commercial Distribution
Version Model Number447.116
Catalog Number447116
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587052922 [Primary]
HIBCCH9804471160 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

[10887587052922]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

H981023060100 - NA2024-07-12 6.0MM PELVIC ROD-LEFT
H981023060120 - NA2024-07-12 6.0MM PELVIC ROD-RIGHT
H981042006140 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
H981042006150 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
H981042006160 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
H981042006170 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
H981042006180 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
H981042006190 - Axon2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.