Model: TLF-SC 10 00-S
DI: 07640221373007
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
PELVIC SETSCREW
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4ed6d27d-29d3-47e5-b3b3-6a8806fbb545
Distribution Status:
In Commercial Distribution
DUNS Number:
483016148
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07640221373007
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
KWP
Appliance, Fixation, Spinal Interlaminal
Premarket Submissions
Submission Number:
K253966
Supplement Number:
000