Arcos® Revision Hip Instrumentation

Basic Information

• Brand Name: Arcos® Revision Hip Instrumentation
• Primary DI: 05019279431557
• Version / Model: 31-301920
• Catalog Number: 31-301920
• Company Name: Biomet Uk Ltd
• Labeler DUNS: 219322575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-29
• Public Version: 2
• Public Version Date: 2021-06-07
• Public Version Status: Update
• Public Device Record Key: 373b3d6a-214c-4ae4-a867-206d7516a9ef

Device Characteristics

• Single Use: No
• 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: 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: Yes
• 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
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate	Orthopedic	888.3353	2
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish	Orthopedic	888.3353	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32390	Fluted surgical drill bit, reusable	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05019279431557	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100469	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Ø3.6 mm