AccessGUDID - DEVICE: NILE™ Alternative Fixation System (10888857000018)

GUDID

Device Identifier (DI) Information

Brand Name: NILE™ Alternative Fixation System
Version or Model: 5416-F03730-SG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5416-F03730-SG
Company Name: K2M, INC.

Primary DI Number: 10888857000018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Band Size 3 mm

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44797	Internal spinal fixation system cable	An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWI	Bone fixation cerclage, sublaminar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 3 Millimeter

Device Record Status

Public Device Record Key: 07f9e446-d9d5-4805-ab2c-6c313a5b76cc
Public Version Date: July 22, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015