DEVICE: SYNFIX Evolution (10705034814063)

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Device Identifier (DI) Information

SYNFIX Evolution
03.835.001
03835001
SYNTHES (U.S.A.) LP
10705034814063
GS1
1
SYNFIX® EVOLUTION AIMING DEVICE/10.5MM & 12MM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic implant aiming/guiding block A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes of various sizes and shapes in it used by the surgeon to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of high-grade stainless steel or synthetic materials and will typically have a connecting bolt in its centre for attachment to the implant. The surgeon can ascertain the correct placement of the implant and that the bone screws used to fix the plate in place are at the correct angle to the anatomy of the bone. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
OVD Intervertebral fusion device with integrated fixation, lumbar
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
June 30, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
HIBCC H981038350010
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
Yes
07611819658097
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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