Advansys DLP/MLP

Basic Information

• Brand Name: Advansys DLP/MLP
• Primary DI: 10381780064374
• Version / Model: ADVANMID
• Catalog Number: ADVANMID
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 9
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: 5e5dece5-8720-40c6-8dba-c223ef3bf545
• Distribution End Date: 2024-07-02

Device Description

The Advansys Midfoof Complete set includes Lisfranc plates, Lapidus plates, screws, and instruments used to guide the implants, including K-wire. The Lisfranc Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is available in different sizes and is implanted using the locking system fixation screws and washers. Lisfranc Plates are intended for fractures, fusions, osteotomies and replantation of small bones at the tarsometatarsal joints. The Lapidus Plate consists of an osteosynthesis plate designed to bridge the first tarometatarsal joint.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.	Yes	Active
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780064374	GS1
Secondary	M248ADVANMID1	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place.