INHANCE

Basic Information

• Brand Name: INHANCE
• Primary DI: 10603295546993
• Version / Model: 5500-00-368
• Catalog Number: 550000368
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-16
• Public Version: 1
• Public Version Date: 2022-05-24
• Public Version Status: New
• Public Device Record Key: 6faf0244-8462-4bd9-883a-01740f9e32fe

Device Description

INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL MEDIUM Ø36+8mm

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
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED	Orthopedic	888.3690	2
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3650	2
PHX	shoulder prosthesis, reverse configuration	Orthopedic	888.3660	2
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
MBF	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED	Orthopedic	888.3670	2
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60511	Reverse shoulder prosthesis body	A sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295546993	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K212737	000