Device
MIS Pre-Bent Rod, Ø5.5mm X 190mm
Manufacturer
Xtant Medical Holdings, Inc.
Model: 04-55-PR-190 Catalog: 04-55-PR-190 DI: 00840311244966 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
MIS Pre-Bent Rod, Ø5.5mm X 190mm
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: eb1f0895-c0e6-490d-a355-b05398cd14f7
Distribution Status: In Commercial Distribution
DUNS Number: 081224143
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
Item #1 - Device ID: 00191083019017
Item #1 - Device ID Type: Previous
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00840311244966
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 65116
Name: Bone-screw internal spinal fixation system rod
Definition:
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder 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)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
FDA Product Codes
NKB
Thoracolumbosacral pedicle screw system
MNH
Orthosis, spondylolisthesis spinal fixation
MNI
Orthosis, spinal pedicle fixation
Premarket Submissions
Submission Number: K192396
Supplement Number: 000