FlexitSystem

Basic Information

• Brand Name: FlexitSystem
• Primary DI: 03701173701769
• Version / Model: S02TL35
• Catalog Number: S02TL35
• Company Name: NEOSTEO
• Labeler DUNS: 261106831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-02
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: e36dcfce-21cc-444f-81d3-6d11ba8ec399

Device Description

Locking screw, Ø5mm length 35mm

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701173701769	GS1

Premarket Submissions

Submission Number	Supplement Number
K212545	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter 5mm, Length 35mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Device must be stored in a place protected from light and humidity.