MANZA HEADS

Basic Information

• Brand Name: MANZA HEADS
• Primary DI: 00841176103245
• Version / Model: 103-51-080
• Catalog Number: 103-51-080
• Company Name: STINSON ORTHOPEDICS INC.
• Labeler DUNS: 080460688
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b49a3015-4c39-4167-80a8-c19eaaa69e87

Device Description

MANZA TAPER SLEEVE OFFSET, +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: 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
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	888.3360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59688	Femoral head/stem prosthesis adaptor	A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841176103245	GS1

Premarket Submissions

Submission Number	Supplement Number
K143184	000