04112624S

GUDID 07612334214461

2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS3/ LEFT/ STERILE

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile

Primary Device ID	07612334214461
NIH Device Record Key	d6bb3bbe-055b-4584-933c-573e325dd35f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	04.112.624S
Catalog Number	04112624S
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334214461 [Direct Marking]
GS1	10886982279286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201321

FDA Product Code

HRS	Plate, fixation, bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

[07612334214461]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-03-01
Device Publish Date	2021-02-19

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

10886982297280 - NA	2024-09-11 SCHANZ PIN REMOVAL TOOL
H9814871830 - Click'X	2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
H9812982060 - NA	2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA	2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA	2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA	2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA	2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA	2024-07-24 3.5MM SHAFT SCREW 38MM

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