Comprehensive® Reverse Shoulder

Basic Information

• Brand Name: Comprehensive® Reverse Shoulder
• Primary DI: 00880304555402
• Version / Model: 180559
• Catalog Number: 180559
• 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: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 5bc3a0dc-ae93-44d5-80b7-3de664be91d2

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: 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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3650	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2
MBF	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED	Orthopedic	888.3670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48094	Shoulder prosthesis screw	A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00880304555402	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080642	000
K130390	000
K132239	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.75mm Ø x 25mm Length x 3.5mm Hex