249691

GUDID H6792496910

2.4/2.7MM LOCKING HIND/MIDFOOT PLATE 8 HOLES/45MM

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile

Primary Device ID	H6792496910
NIH Device Record Key	24c7eba1-8089-46bf-88e0-d81f475b024c
Commercial Distribution Status	In Commercial Distribution
Version Model Number	249.691
Catalog Number	249691
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
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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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982171375 [Primary]
HIBCC	H6792496910 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K071264

FDA Product Code

HRS	PLATE, FIXATION, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

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[H6792496910]

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[H6792496910]

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[H6792496910]

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[H6792496910]

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[H6792496910]

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[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

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[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

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[H6792496910]

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[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

[H6792496910]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-04-29
Device Publish Date	2015-09-14

Devices Manufactured by Synthes GmbH

07612334285515 - VOLT	2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY
10886982346896 - MAXFRAME	2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE
10886982347572 - NA	2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE
10886982330994 - VOLT	2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM
07612334260079 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
07612334268679 - KINCISE	2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
07612334268563 - KINCISE	2024-11-04 KINCISE™ System Automated Surgical Handpiece V2

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