iTotal® Hip Replacement System HAA0300640

GUDID M572HAA0300640011

HIP-SCREW-6.5MM X 40MM

Conformis, Inc.

Polyethylene acetabulum prosthesis

• Primary Device ID: M572HAA0300640011
• NIH Device Record Key: bcc146bf-fe6b-4ccc-bee9-de0350522bcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® Hip Replacement System
• Version Model Number: HAA030064001
• Catalog Number: HAA0300640
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572HAA0300640011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162719

FDA Product Code

• OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-08-15
• Device Publish Date: 2018-07-30

On-Brand Devices [iTotal® Hip Replacement System]

• M572HAH01036XL011: N/A
• M572HAH01036SH011: N/A
• M572HAH01036MD011: N/A
• M572HAH01036LG011: N/A
• M572HAH01032XL011: N/A
• M572HAH01032SH011: N/A
• M572HAH01032MD011: N/A
• M572HAH01032LG011: N/A
• M572HAH01028XL011: N/A
• M572HAH01028SH011: N/A
• M572HAH01028MD011: N/A
• M572HAH01028LG011: N/A
• M572HAH04040XL011: N/A
• M572HAH04040SH011: N/A
• M572HAH04040MD011: N/A
• M572HAH04040LG011: N/A
• M572HAH04036XL011: N/A
• M572HAH04036SH011: N/A
• M572HAH04036MD011: N/A
• M572HAH04036LG011: N/A
• M572HAH04032XL011: N/A
• M572HAH04032SH011: N/A
• M572HAH04032MD011: N/A
• M572HAH04032LG011: N/A
• M572HAH04028SH011: N/A
• M572HAH04028MD011: N/A
• M572HAH04028LG011: N/A
• M572HDL060F34S011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +4 STD
• M572HDL060F32S011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 STD (PLN)
• M572HDL060F32L011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 LIP
• M572HDL060F32F011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 FC
• M572HDL060F30S011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 STD
• M572HDL060F30L011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 LIP
• M572HDL060F30F011: HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 FC
• M572HDL060F24S011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +4 STD
• M572HDL060F22S011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 STD (PLN)
• M572HDL060F22L011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 LIP
• M572HDL060F22F011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 FC
• M572HDL060F20S011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 STD
• M572HDL060F20L011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 LIP
• M572HDL060F20F011: HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +0 FC
• M572HDL060E34S011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +4 STD
• M572HDL060E32S011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 STD (PLN)
• M572HDL060E32L011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 LIP
• M572HDL060E32F011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 FC
• M572HDL060E30S011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 STD
• M572HDL060E30L011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 LIP
• M572HDL060E30F011: HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC
• M572HDL060E24S011: HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +4 STD
• M572HDL060E22S011: HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +2 STD (PLN)