Device
Rod: Ø 5.5 mm, Length 45 mm , Straight end,
Manufacturer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model: AISP-1517-5501 Catalog: 1517-5501 DI: 00840185365392 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-16 Current Version: 2026-05-25
Description
Rod: Ø 5.5 mm, Length 45 mm , Straight end, Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 3cfd6a6c-ee79-4e18-a314-3f8f4f67cf58
Distribution Status: In Commercial Distribution
DUNS Number: 868354728
Device Count: 1
DM Exempt: Yes
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00840185365392
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46650
Name: Spinal bone screw, bioabsorbable
Definition:
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 stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
Premarket Submissions
Submission Number: K202498
Supplement Number: 000