AccessGUDID - DEVICE: Cannulated Tapered Pedicle Screw (07290115933765)

GUDID

Device Identifier (DI) Information

Brand Name: Cannulated Tapered Pedicle Screw
Version or Model: 88676
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PREMIA SPINE LTD

Primary DI Number: 07290115933765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649220779 *Terms of Use

Device Description: Cannulated Tapered Pedicle Screw 5.5X50[mm] used for fixation of spinal implants to the vertebrae.

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
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231844	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 Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 22 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Millimeter
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: 6a120057-c532-4371-953b-3c2bb7d3bc1b
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: December 12, 2023