Osseointegration Prosthetic Limb

Basic Information

• Brand Name: Osseointegration Prosthetic Limb
• Primary DI: 19356371001015
• Version / Model: M10 Grub Screw Left Connector
• Catalog Number: OPL-LLCM10-TF-L
• Company Name: OSSEOINTEGRATION INTERNATIONAL PTY LTD
• Labeler DUNS: 743779676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-16
• Public Version: 1
• Public Version Date: 2022-12-26
• Public Version Status: New
• Public Device Record Key: b92f14f3-764f-42e7-a6ca-a99ad3a6f30b

Device Description

Left Femoral Connector Assembly – M10

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IQO	Device, Prosthesis Alignment	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61229	External lower-limb prosthesis structural/alignment component	A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	19356371001015	GS1