Cordera HDA-050-E32S

GUDID M572HDA050E32S011

CORDERA LINER TRIAL GRP E range 58-63 40MM plus2 STD

Conformis, Inc.

Acetabulum prosthesis trial, prefabricated, single-use

• Primary Device ID: M572HDA050E32S011
• NIH Device Record Key: eb9b4b31-5df1-4ac2-b163-1dadd57c3a5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cordera
• Version Model Number: HDA-050-E32S-01
• Catalog Number: HDA-050-E32S
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M572HDA050E32S011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202484

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [Cordera]

• M572HDA050F32S011: CORDERA LINER TRIAL GRP F range 64-66 40MM plus2 STD
• M572HDA050F22S011: CORDERA LINER TRIAL GRP F range 64-66 36MM plus2 STD
• M572HDA050E32S011: CORDERA LINER TRIAL GRP E range 58-63 40MM plus2 STD
• M572HDA050E22S011: CORDERA LINER TRIAL GRP E range 58-63 36MM plus2 STD
• M572HDA050D32S011: CORDERA LINER TRIAL GRP D range 54-57 40MM plus2 STD
• M572HDA050D22S011: CORDERA LINER TRIAL GRP D range 54-57 36MM plus2 STD
• M572HDA050C22S011: CORDERA LINER TRIAL GRP C range 50-53 36MM plus2 STD
• M572HDA050B12S011: CORDERA LINER TRIAL GRP B range 46-49 32MM plus2 STD