Model: 8699050
DI: 00763000887346
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Description
ROD 8699050 CDH 5.5X50 STRAIGHT TI CP
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:
4ddc17d4-6f15-4338-ae6c-c512dfa54e4e
Distribution Status:
In Commercial Distribution
DUNS Number:
830350380
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:
00763000887346
Type:
Primary
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
MNH
Orthosis, spondylolisthesis spinal fixation
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI
Orthosis, spinal pedicle fixation
KWQ
Appliance, fixation, spinal intervertebral body
Premarket Submissions
Submission Number:
K981676
Supplement Number:
000