System 12

Basic Information

• Brand Name: System 12
• Primary DI: 07613327545227
• Version / Model: AA
• Catalog Number: C-M111-2-700
• Company Name: Howmedica Osteonics Corp.
• Labeler DUNS: 058311945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 1
• Public Version Date: 2020-12-02
• Public Version Status: New
• Public Device Record Key: 263be744-2688-4063-8299-8bd12be8f929

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 Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	57613327545222	GS1	case	1	In Commercial Distribution
Package	37613327545228	GS1	pack	1	In Commercial Distribution
Primary	07613327545227	GS1

Premarket Submissions

Submission Number	Supplement Number
K951114	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Acetabular Insert: P1