Reform Pedicle Screw System

Basic Information

• Brand Name: Reform Pedicle Screw System
• Primary DI: 00815362028131
• Version / Model: 39-MS-1080
• Catalog Number: 39-MS-1080
• Company Name: PRECISION SPINE, INC.
• Labeler DUNS: 079398589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-15
• Public Version: 5
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: ba0e2cd1-d664-4df3-a258-44c76bfd6181

Device Description

Modular Polyaxial Bone Screw Ø10.5mm x 80mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	888.3070	2
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67309	Spinal fixation implant/sterilization container set	A collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815362028131	GS1

Premarket Submissions

Submission Number	Supplement Number
K150856	000