Calcar Planer Adapter Drop-in 1080-700

GUDID 00810933031817

Calcar Planer Adapter Drop-in ED-09733

Conformis, Inc.

Joint prosthesis implantation kit, single-use

• Primary Device ID: 00810933031817
• NIH Device Record Key: 2184d567-b6a9-4348-aa4f-1fddd14fe955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcar Planer Adapter Drop-in
• Version Model Number: 1080-700
• Catalog Number: 1080-700
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
GS1	00810933031817 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

[00810933031817]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-13
• Device Publish Date: 2023-12-05

Devices Manufactured by Conformis, Inc.

• M572TCR000D00F021 - Identity Imprint CR Knee Replacement System: 2024-07-04 CR FEMORAL INSTRUMENTS,ALL SIZES LEFT AND RIGHT
• M572TCR000D00T021 - Identity Imprint CR Knee Replacement System: 2024-07-04 CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT
• M572TPS000D00F021 - Identity Imprint PS Knee Replacement System: 2024-07-04 PS Femoral INSTRUMENTS,ALL SIZES LEFT AND RIGHT
• M572TCR302T07S011 - Identity Imprint Porous CR: 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
• 00810933031817 - Calcar Planer Adapter Drop-in: 2023-12-13Calcar Planer Adapter Drop-in ED-09733
• 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