AccessGUDID - DEVICE: InSpan® (00190361000570)

GUDID

Device Identifier (DI) Information

Brand Name: InSpan®
Version or Model: IM61000-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SPINEFRONTIER, INC.

Primary DI Number: 00190361000570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002003243 *Terms of Use

Device Description: ISP Plate, 8x41mm

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:	Yes
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

[?]

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

GMDN Preferred Term Name	GMDN Definition
Interspinous spinal fixation implant	A non-sterile implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Interspinous spinal fixation implant

A non-sterile implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device intended to be sterilized prior to use.

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102020	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

[?]

Size Type Text
Width: 8 Millimeter
Length: 41 Millimeter

Device Record Status

Public Device Record Key: 92a9237e-6bf6-4024-b972-f5dc028e7062
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 15, 2016