DJO SURGICAL

Basic Information

• Brand Name: DJO SURGICAL
• Primary DI: 00190446254522
• Version / Model: 540-65-115
• Company Name: Encore Medical, L.P.
• Labeler DUNS: 154074504
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-28
• Public Version: 1
• Public Version Date: 2019-04-05
• Public Version Status: New
• Public Device Record Key: d5647e70-d667-4f99-aa60-aa2d21307efc

Device Description

DISC ULNA 5X115MM RT W/ E+ BRNG

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
JDC	PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED	Orthopedic	888.3150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33173	Metal-backed elbow ulna prosthesis	A sterile implantable device designed to replace the proximal ulna as part of an elbow joint replacement. The device is typically comprised of metal-backed polyethylene (PE) and its stem is usually coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190446254522	GS1

Premarket Submissions

Submission Number	Supplement Number
K013042	000