AccessGUDID - DEVICE: ENDOSKELETON® TCS (00191375011736)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON® TCS
Version or Model: 5086-1605
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5086-1605
Company Name: TITAN SPINE, LLC

Primary DI Number: 00191375011736
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: 6 DEG LORDOTIC, TRIAL, LARGE, 5MM

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 implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Spinal implant trial

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142940	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
Device Size Text, specify: 18 x 16 (M/L x A/P) mm
Device Size Text, specify: Lordotic Angle 6 Deg
Height: 5 Millimeter

Device Record Status

Public Device Record Key: 7883e530-a3df-4aa2-a8b4-64bb27ad755f
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: December 15, 2016