AccessGUDID - DEVICE: TRYPTIK®2 C-Plate Anterior Cervical Plate System (07640151094898)

GUDID

Device Identifier (DI) Information

Brand Name: TRYPTIK®2 C-Plate Anterior Cervical Plate System
Version or Model: TRY-CP 10 88-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TRY-CP 10 88-S
Company Name: SpineArt SA

Primary DI Number: 07640151094898
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: 4 LEVEL PLATE LENGTH 88 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?
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; 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 (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, Fixation, Spinal Intervertebral Body

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 88 Millimeter

Device Record Status

Public Device Record Key: 257bcf0d-1c9f-4941-a424-d026a8667bdb
Public Version Date: March 31, 2025
Public Version Number: 6
DI Record Publish Date: July 12, 2016