Model: TLF-RC CC 00-S
DI: 07640221372994
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
ARTICULATED ROD CONNECTOR, CLOSED/CLOSED
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
60ad6b02-a8c9-4469-b475-c90a846c6157
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:
07640221372994
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65114
Name: Bone-screw internal spinal fixation system connector
Definition:
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
FDA Product Codes
NKB
Thoracolumbosacral Pedicle Screw System
KWP
Appliance, Fixation, Spinal Interlaminal
Premarket Submissions
Submission Number:
K253966
Supplement Number:
000