Model: 7673025
DI: 00763000874308
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
SCREW 7673025 4.5 SHILLA FAS 5.0X25
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:
9b9fe641-b2c6-403b-8755-8c9cebe94bad
Distribution Status:
In Commercial Distribution
DUNS Number:
830350380
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00763000874308
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46651
Name: Spinal bone screw, non-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 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.
FDA Product Codes
PGM
Growing rod system
Premarket Submissions
Submission Number:
K140750
Supplement Number:
000