Model: 03.47.152
DI: 07630542758645
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
MUST Connector Ti Setscrew (4x)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eb474a5b-958a-4118-a63d-a9367c7cd216
Distribution Status:
In Commercial Distribution
DUNS Number:
488227125
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07630542758645
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65553
Name: Spinal bone set screw
Definition:
A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).
FDA Product Codes
NKB
Thoracolumbosacral pedicle screw system
Premarket Submissions
Submission Number:
K253940
Supplement Number:
000