Model: 10250112P
Catalog: 10250112P
DI: 00887517049315
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
RSS Iliac Saddle, 5.0mm Straight Ø12
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5bbf44d9-675f-4e40-a2fc-b1b374cf7fc4
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00887517049315
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65115
Name: Bone-screw internal spinal fixation system hook
Definition:
An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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 typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.
FDA Product Codes
KWP
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ
Appliance, fixation, spinal intervertebral body
NKB
Thoracolumbosacral pedicle screw system
Premarket Submissions
Submission Number:
K190636
Supplement Number:
000