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

[?]

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, reusable A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.
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FDA Product Code

[?]
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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
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

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
07611819658097
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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