Pyramesh® Implant System

Basic Information

• Brand Name: Pyramesh® Implant System
• Primary DI: 00673978080949
• Version / Model: 905-412
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-24
• Public Version: 6
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: c25235a0-af88-4e60-a3fd-6423f012a9fd

Device Description

MESH 905-412 PYRM 10 X 14 OVOID X 12MM

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZX	Mesh, surgical, metal	General, Plastic Surgery	878.3300	2
MQP	Spinal vertebral body replacement device	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46580	Extra-gynaecological surgical mesh, metal	A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673978080949	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183197	000
K890601	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10mm x 14mm x 12 mm