DEVICE: Arena-C® (00190361021018)

Device Identifier (DI) Information

Arena-C®
01-72001-07
In Commercial Distribution

SPINEFRONTIER, INC.
00190361021018
GS1

1
002003243 *Terms of Use
Arena-C, Lordotic, 12x15x7mm
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Polymeric spinal fusion cage, non-sterile A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
ODP Intervertebral fusion device with bone graft, cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113518 000
No CLOSE

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
Width: 15 Millimeter
Length: 12 Millimeter
Height: 7 Millimeter
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Device Record Status

b2dd19c4-1274-4d6a-b041-de11fd302e5b
July 06, 2018
3
April 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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(866)914-7717
customerservice@spinefrontier.com
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