AccessGUDID - DEVICE: X-CORE (00887517244093)

GUDID

Device Identifier (DI) Information

Brand Name: X-CORE
Version or Model: 5163014
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nuvasive, Inc.

Primary DI Number: 00887517244093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053950783 *Terms of Use

Device Description: X-CORE 2 Ti Endcap, Ø16x16x30mm -4°

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090176	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d42b7c6-37e9-4c38-b4c7-be57b927da2b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015