DJO SURGICAL

Basic Information

• Brand Name: DJO SURGICAL
• Primary DI: 00190446673224
• Version / Model: 952-28-46H
• Company Name: Encore Medical, L.P.
• Labeler DUNS: 154074504
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-12
• Public Version: 2
• Public Version Date: 2022-06-27
• Public Version Status: Update
• Public Device Record Key: 0a91426b-2eae-4b34-b141-3e61ded200aa

Device Description

EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD46

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: Yes
• 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
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65063	Bipolar femoral head outer component, total arthroplasty	An implantable hemisphere-shaped device used as part of a total hip arthroplasty (THA) and designed to interface with the acetabular liner on its outer surface where it freely rotates, and encompass/interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head; it is not a femoral head prosthesis. It is a one-piece device made of polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190446673224	GS1

Premarket Submissions

Submission Number	Supplement Number
K203557	000