Apex

Basic Information

• Brand Name: Apex
• Primary DI: 05391529580179
• Version / Model: LS01-50050
• Company Name: ORTHOXEL DESIGNATED ACTIVITY COMPANY
• Labeler DUNS: 985596830
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 6bac864c-7957-489a-a400-0998d2bdb289

Device Description

Apex Tibial Screw, Sterile

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391529580179	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170972	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5x50mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Ambient Temperature and Humidity