Model: 12100260
Catalog: 12100260
DI: 00887517793225
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
RSS Conn, 4.5/5.0-5.0/6.0mm Rod O-H
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:
0d3e6632-0379-4cce-83eb-4d58f9f7166f
Distribution Status:
In Commercial Distribution
DUNS Number:
053950783
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:
00887517793225
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
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ
Appliance, fixation, spinal intervertebral body
NKB
Thoracolumbosacral pedicle screw system
Premarket Submissions
Submission Number:
K170126
Supplement Number:
000