AccessGUDID - DEVICE: Fuse ULTRA Foot plating System (B565OS2004001)

GUDID

Device Identifier (DI) Information

Brand Name: Fuse ULTRA Foot plating System
Version or Model: OS200400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS200400
Company Name: CPM Medical Consultants, LLC

Primary DI Number: B565OS2004001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017138000 *Terms of Use

Device Description: Drill/Countersink combo QC 4.0 Cannulated Screw

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:	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?
16462	Surgical countersink, reusable	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWW	Countersink

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141784	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: 8e0bab08-11a5-4bf2-a4f6-2b21c980f0a4
Public Version Date: March 19, 2025
Public Version Number: 2
DI Record Publish Date: September 08, 2023