AccessGUDID - DEVICE: Trigon (00810005669306)

GUDID

Device Identifier (DI) Information

Brand Name: Trigon
Version or Model: CC-2525-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00810005669306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047486041 *Terms of Use

Device Description: Implant PEEK CC Wedge, 8mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

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?
61330	Polymeric osteotomy fusion cage, non-customized	A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLF	Bone Wedge
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223226	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: 25 Millimeter
Depth: 25 Millimeter
Device Size Text, specify: 8mm Thick

Device Record Status

Public Device Record Key: 62339e69-8412-40f8-b97f-c57324f1d436
Public Version Date: June 14, 2023
Public Version Number: 1
DI Record Publish Date: June 06, 2023