Device
Rod: Ø 5.5 mm, Length 55 mm , Straight end,
Manufacturer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model: AISP-1517-5501
Catalog: 1517-5501
DI: 00840185382139
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 55 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:
858237f9-c114-4ecb-a7e7-440120d7e1be
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:
00840185382139
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