Biomet®

Basic Information

• Brand Name: Biomet®
• Primary DI: 00880304527812
• Version / Model: 010001034
• Catalog Number: 010001034
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 6
• Public Version Date: 2023-04-24
• Public Version Status: Update
• Public Device Record Key: a50e1c9f-5d75-4d1d-8a62-ee31615d72bf

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented	Orthopedic	888.3353	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive	Orthopedic	888.3310	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented	Orthopedic	888.3358	2
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented	Orthopedic	888.3350	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
LWZ	TISSUE GRAFT OF LESS THAN 6MM	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33175	Metallic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304527812	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121874	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			40 mm Head Size +3 Neck Length