AccessGUDID - DEVICE: APEX 3D Total Ankle Replacement System (00889795011930)

GUDID

Device Identifier (DI) Information

Brand Name: APEX 3D Total Ankle Replacement System
Version or Model: P10-931-I219
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P10-931-I219
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795011930
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: Total Ankle, Instrument, Poly Trial Insert, Size 2, 19MM, 3.25MM ANT/POST Offset, PPSU

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	Active	false

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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: f0307f3c-c2f6-47fe-ac0c-1978659e681f
Public Version Date: April 22, 2025
Public Version Number: 2
DI Record Publish Date: October 14, 2022