Tornier Perform Humeral System

Basic Information

• Brand Name: Tornier Perform Humeral System
• Primary DI: 00846832093397
• Version / Model: PFX00034
• Catalog Number: PFX00034
• Company Name: TORNIER, INC.
• Labeler DUNS: 968990812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-21
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: b40496c8-3396-4cbc-8dfb-2649938da88b

Device Description

Fracture Stem Screw

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: Yes
• Has Lot/Batch Number: No
• 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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED	Orthopedic	888.3660	2
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
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	888.3660	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	00846832093397	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	34	Millimeter