AccessGUDID - DEVICE: Facet screw (07290019421238)

GUDID

Device Identifier (DI) Information

Brand Name: Facet screw
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZF-40FS-20TU
Company Name: ZYGOFIX LTD

Primary DI Number: 07290019421238
Issuing Agency: GS1
Commercial Distribution End Date: September 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 532143561 *Terms of Use

Device Description: The subjected screw is part of the zLOCK Lumbar Facet Fixation System. The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set.

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?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRW	System, Facet Screw Spinal Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240085	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
Storage Environment Atmospheric Pressure: between 700 and 1013 millibar
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aef19879-3623-4e5d-9d47-939ad88c0d34
Public Version Date: October 21, 2024
Public Version Number: 3
DI Record Publish Date: September 05, 2024