ProMIS™ Fixation System

Basic Information

• Brand Name: ProMIS™ Fixation System
• Primary DI: 07290014080720
• Version / Model: 86874
• Company Name: PREMIA SPINE LTD
• Labeler DUNS: 649220779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-17
• Public Version: 1
• Public Version Date: 2024-01-25
• Public Version Status: New
• Public Device Record Key: c362e3bd-0865-4ae7-9bff-762349727f58

Device Description

Pre Bent Rod Ø6.0x220mm Hex Edge The ProMIS Fixation System is designed to be implanted in the lumbar spine. The ProMIS Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease	Orthopedic	888.3070	2
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	888.3070	2
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61325	Bone-screw internal spinal fixation system, non-sterile	An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290014080720	GS1

Premarket Submissions

Submission Number	Supplement Number
K150380	000
K170061	000
K231844	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	6	Millimeter
Length	220	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 22 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 70 Percent (%) Relative Humidity