414014

GUDID H6794140140

4.5MM TI CORTEX SCREW 14MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw (non-sliding)
Primary Device IDH6794140140
NIH Device Record Key072bf0e0-82ca-4fee-b4c3-d0e8de5a1ddf
Commercial Distribution Discontinuation2023-08-30
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number414.014
Catalog Number414014
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982212344 [Primary]
HIBCCH6794140140 [Secondary]

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


[H6794140140]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-27
Device Publish Date2015-09-14

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

H981PDL432F - NA2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA2026-02-09 TAMP
07611819943490 - NA2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.