201688

GUDID H6792016880

2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 36MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device IDH6792016880
NIH Device Record Key4bca2d5b-5817-448b-9410-181963b41b39
Commercial Distribution StatusIn Commercial Distribution
Version Model Number201.688
Catalog Number201688
Company DUNS486711679
Company NameSynthes GmbH
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982142542 [Primary]
HIBCCH6792016880 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

[H6792016880]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

10887587078359 - NA2024-04-16 MANDIBLE BODY REDUCTION HANDLE
10886982344427 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/TIBIAL FIXTN/LNG/STER
10886982344434 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
10886982345745 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
10886982345752 - NA2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
H67904038070S0 - TFN-ADVANCE2024-02-27 TFNA SCREW 70MM - STERILE
H6792161400 - NA2024-02-27 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/140MM
H6792180750 - NA2024-02-27 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/75MM
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.