458880S

GUDID H679458880S0

4.0MM TI LOCKING SCREW 80MM- FOR IM NAILS-STERILE

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDH679458880S0
NIH Device Record Key6e5440be-3353-4c46-b3cb-b4d82913b2b7
Commercial Distribution Discontinuation2019-09-20
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number458.880S
Catalog Number458880S
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982230706 [Primary]
HIBCCH679458880S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDSNAIL, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679458880S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-20
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

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