Compress Device

Basic Information

• Brand Name: Compress Device
• Primary DI: 00880304260399
• Version / Model: 178512
• Catalog Number: 178512
• 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: 4
• Public Version Date: 2020-11-03
• Public Version Status: Update
• Public Device Record Key: deda7fb3-6b63-446a-80f3-969b53af7723

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 Conditional
• 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
KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER	Orthopedic	888.3510	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	Orthopedic	888.3390	2
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate	Orthopedic	888.3353	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32847	Orthopaedic bone nut	A sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304260399	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031804	000
K043547	000