AccessGUDID - DEVICE: Toe MotionTM (M5289P15PA01A0)

GUDID

Device Identifier (DI) Information

Brand Name: Toe MotionTM
Version or Model: 9P15-PA01-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9P15-PA01-A
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M5289P15PA01A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: Modular Insert, 1.5mm Offset -01 (3.6mm thick)

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?
61601	Total metatarsophalangeal joint prosthesis, modular	An implantable substitute for the metatarsophalangeal (MTP) joint of the foot (toe) intended to repair both articulating surfaces with matching metatarsal and phalangeal components, typically to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and polymer materials and implantation may be performed with or without bone cement. Disposable instruments associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132496	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: 7de29360-e83b-4787-86b5-16166866897b
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: September 15, 2015