ACTERA FEMORAL BROACH, SIZE 09 1080-684

GUDID 00810933031527

ACTERA FEMORAL BROACH, SIZE 09

Conformis, Inc.

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: 00810933031527
• NIH Device Record Key: b5210551-fb1a-429e-8865-a29b4434c8e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTERA FEMORAL BROACH, SIZE 09
• Version Model Number: 1080-684
• Catalog Number: 1080-684
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810933031527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221104

FDA Product Code

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

Sterilization

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

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

[00810933031527]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-10
• Device Publish Date: 2022-11-02

Devices Manufactured by Conformis, Inc.

• M572TCR302T07S011 - Identity Imprint Porous CR: 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
• 00810933031817 - Calcar Planer Adapter Drop-in: 2023-12-13 Calcar Planer Adapter Drop-in ED-09733
• M572POV0123208011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly
• M572POV0123509011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly
• M572POV0123809011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly
• M572POV0124110011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 41MM X 10MM, iPoly
• M572POV0124411011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 44MM X 11MM, iPoly
• M572TCR102F01S011 - Identity Imprint Porous CR: 2023-09-18 POROUS CR FEMORAL IMPLANT SIZE 1 LEFT OR RIGHT