AccessGUDID - DEVICE: StruXure (00887517088994)

GUDID

Device Identifier (DI) Information

Brand Name: StruXure
Version or Model: 1637200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nuvasive, Inc.

Primary DI Number: 00887517088994
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053950783 *Terms of Use

Device Description: StruXure Ti Rod, 200mm Straight

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
Spinal bone screw, non-bioabsorbable	A small, sterile, threaded rod with a slotted head used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

GMDN Preferred Term Name

GMDN Definition

Spinal bone screw, non-bioabsorbable

A small, sterile, threaded rod with a slotted head used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

FDA Product Code

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Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111410	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: 6fc2e5a3-03df-46a8-baf0-f98e0c66a326
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015