AccessGUDID - DEVICE: Fuse Pedicle Screw System (B565FZSC1001)

GUDID

Device Identifier (DI) Information

Brand Name: Fuse Pedicle Screw System
Version or Model: Rev C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FZ-SC100
Company Name: CPM Medical Consultants, LLC

Primary DI Number: B565FZSC1001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017138000 *Terms of Use

Device Description: Set Caps

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?
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182283	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: 6143b862-a808-4d15-8c0d-2cee3b7bf27c
Public Version Date: July 14, 2025
Public Version Number: 5
DI Record Publish Date: June 26, 2020