02100120

GUDID H679021001200

3.5MM LOCKING LOW PROFILE RECON PLATE 20 HOLES

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile

Primary Device ID	H679021001200
NIH Device Record Key	7a8e5847-e2b3-4ac7-9c31-bac28f4e056f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	02.100.120
Catalog Number	02100120
Company DUNS	486711679
Company Name	Synthes GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
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	false
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
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
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	10886982028532 [Primary]
HIBCC	H679021001200 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042377

FDA Product Code

HRS	PLATE, FIXATION, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

[H679021001200]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-04-28
Device Publish Date	2015-09-14

Devices Manufactured by Synthes GmbH

10886982322982 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 44MM T8
10886982322999 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 44MM T8 STERILE
10886982323002 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8
10886982323019 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8 STERILE
10886982323026 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8
10886982323033 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8 STERILE
10886982323040 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8
10886982323057 - VOLT	2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8 STERILE

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