Device
RSS Iliac Saddle, 5.0mm Straight Ø12
Manufacturer
Nuvasive, Inc.
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