AccessGUDID - DEVICE: aBle Spinal Fixation System (00840185340887)

GUDID

Device Identifier (DI) Information

Brand Name: aBle Spinal Fixation System
Version or Model: AISP-2001-7590
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2001-7590
Company Name: SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Primary DI Number: 00840185340887
Issuing Agency: GS1
Commercial Distribution End Date: April 29, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 868354728 *Terms of Use

Device Description: The aBle Spinal Fixation System is a minimally invasive spinal fixation device used to stabilize the thoracic and lumbar spine during fusion surgery. It consists of polyaxial, cannulated pedicle screws, rods, set screws, and a cross-link, allowing percutaneous insertion with minimal tissue damage.

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:	Yes
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 [?]
K232607	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
Length: 7.5 Millimeter

Device Record Status

Public Device Record Key: 12da902d-c662-4fa0-8b60-d3847b158932
Public Version Date: May 07, 2026
Public Version Number: 1
DI Record Publish Date: April 29, 2026