AccessGUDID - DEVICE: Endoskeleton TC (M68251461208S0)

GUDID

Device Identifier (DI) Information

Brand Name: Endoskeleton TC
Version or Model: 5146-1208-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5146-1208-S
Company Name: TITAN SPINE, LLC

Primary DI Number: M68251461208S0
Issuing Agency: HIBCC
Commercial Distribution End Date: September 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: Interbody Fusion Device 6 Degree Small 8mm

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?
38161	Metallic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral fusion device with bone graft, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100889	000
K142589	000

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
Device Size Text, specify: Lordotic Angle 6 Deg
Height: 8 Millimeter
Angle: 6 degree
Device Size Text, specify: width(MLxAP), 14 x 12, mm
Width: 14 Millimeter
Depth: 12 Millimeter

Device Record Status

Public Device Record Key: 4a976016-fa8e-4fda-8c18-4e41196a7524
Public Version Date: December 09, 2020
Public Version Number: 7
DI Record Publish Date: September 17, 2015