DEVICE: MAGEC® Spinal Bracing and Distraction System (00856719002190)

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Device Identifier (DI) Information

MAGEC® Spinal Bracing and Distraction System
RA002-5555SL
PA0239
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
00856719002190
GS1
1
Spinal bracing and distraction system, 5.5 mm standard rod with 90 mm actuator
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Device Characteristics

MR Unsafe
No
No
Yes
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
Trans-facet-screw internal spinal fixation system A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.
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FDA Product Code

[?]
Product Code Product Code Name
PGN Growing Rod System- Magnetic Actuation
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Outer Diameter: 5.5 Millimeter
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Device Status

In Commercial Distribution
January 15, 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
No Secondary DIs found
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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
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
855-435-5477
csdepartment@ellipse-tech.com
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