Model: LC-02
DI: B515LC020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Solid Wing Swivel, 4.5mm Hex
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:
53934a8d-c9aa-4e04-bdbe-d0b581fc7a91
Distribution Status:
In Commercial Distribution
DUNS Number:
018255727
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B515LC020
Type:
Primary
Issuing Agency:
HIBCC
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:
K170045
Supplement Number:
000