DEVICE: X-CORE (00887517266316)

Device Identifier (DI) Information

X-CORE
5950011
In Commercial Distribution

Nuvasive, Inc.
00887517266316
GS1

1
053950783 *Terms of Use
X-CORE Mini Lock Screw, Endcap
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57806 Vertebral body prosthesis, non-sterile
A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
PLR Spinal Vertebral Body Replacement Device - Cervical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090176 000
K142205 000
K151651 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
No Device Sizes
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Device Record Status

cdff678d-1967-4484-a165-106000a6ddd1
August 16, 2019
4
October 24, 2015
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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
No
No
No CLOSE

Customer Contact

[?]
+1(858)909-1800
RA_UDI@nuvasive.com
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