Streamline® MIS Spinal Fixation System

Basic Information

• Brand Name: Streamline® MIS Spinal Fixation System
• Primary DI: 00846468060077
• Version / Model: 51-GW-300-DULL-SS
• Catalog Number: 51-GW-300-DULL-SS
• Company Name: Pioneer Surgical Technology, Inc.
• Labeler DUNS: 793384496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 7
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 65befb10-df73-4801-be4d-33f2dfa363ca

Device Description

GUIDEWIRE, DULL TIP, SS

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: 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
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION	Orthopedic	888.3070	2
MNH	Orthosis, spondylolisthesis spinal fixation	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	No	Active
58927	Orthopaedic prosthesis implantation positioning instrument, single-use	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00846468060077	GS1

Premarket Submissions

Submission Number	Supplement Number
K130286	000