AccessGUDID - DEVICE: TITAN 3-D Wedge System (00889795018120)

GUDID

Device Identifier (DI) Information

Brand Name: TITAN 3-D Wedge System
Version or Model: P03-EVN-0006-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P03-EVN-0006-S
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795018120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: TITAN 3-D Wedge, Evans, Small, 6mm, Sterile

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61617	Metallic 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), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be 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 metal [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLF	Bone Wedge

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162241	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
No Device Sizes

Device Record Status

Public Device Record Key: 30d46a04-2f06-4177-88ef-2c02a840f365
Public Version Date: April 22, 2025
Public Version Number: 3
DI Record Publish Date: January 16, 2020