AOS LAG SCREW 10.5mm x 115mm

Basic Information

• Brand Name: AOS LAG SCREW 10.5mm x 115mm
• Primary DI: 00848665003987
• Version / Model: S1045-115
• Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
• Labeler DUNS: 117858154
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-02
• Public Version: 5
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: b2d7d5fa-02ec-448e-bb01-bc9924e6430f
• Distribution End Date: 2017-06-02

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33187	Femur nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848665003987	GS1

Premarket Submissions

Submission Number	Supplement Number
K021008	000