AccessGUDID - DEVICE: Cadence Chamfer Cut Total Ankle System (00816847022712)

GUDID

Device Identifier (DI) Information

Brand Name: Cadence Chamfer Cut Total Ankle System
Version or Model: Talus Cutting Guide
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3D SYSTEMS, INC.

Primary DI Number: 00816847022712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085049749 *Terms of Use

Device Description: A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

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:	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?
65079	Osteotomy guide, single-use	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYK	Ankle Arthroplasty Implantation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241326	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
No Device Sizes

Device Record Status

Public Device Record Key: 3378f4ac-d901-4285-9d60-fbb0aabf89ca
Public Version Date: September 20, 2024
Public Version Number: 1
DI Record Publish Date: September 12, 2024