AccessGUDID - DEVICE: INFINITY (00840420122018)

GUDID

Device Identifier (DI) Information

Brand Name: INFINITY
Version or Model: 33630015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00840420122018
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 807201207 *Terms of Use

Device Description: No description.

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?
33582	Mobile-bearing total ankle prosthesis	A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is not attached or moulded to either of the components which is intended to facilitate greater joint range of motion. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSN	PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123954	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: Size: 5

Device Record Status

Public Device Record Key: 4acab293-66e9-4e7e-8abf-bd441459f81d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 01, 2015