DEVICE: PCM (00887517081186)

Device Identifier (DI) Information

PCM
7680465
In Commercial Distribution

Nuvasive, Inc.
00887517081186
GS1

1
053950783 *Terms of Use
Artificial Vertebral Disc, 6.5 mm Large
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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
Cervical total disc replacement prosthesis, sterile A sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is typically made of metal or synthetic materials, or a combination of the two. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below. The device is intended to facilitate motion usually through the sliding action of its smooth surfaces.
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FDA Product Code

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Product Code Product Code Name
MJO Prosthesis, Intervertebral Disc
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P100012 000
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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

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Size Type Text
Depth: 17 Millimeter
Width: 20 Millimeter
Height: 6.5 Millimeter
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Device Record Status

1d275333-d25e-42cb-a22c-dfa3c7b315f1
July 06, 2018
3
September 24, 2014
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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
No Secondary DIs found
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
858-909-1800
RA_UDI@nuvasive.com
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