Seitz Solution Radial Head Implant System 18 x 9mm Radial Head KCHI-1809

GUDID B033KCHI18090

18 x 9mm Radial Head

Kapp Surgical Instrument Co.

Elbow radius prosthesis

• Primary Device ID: B033KCHI18090
• NIH Device Record Key: 6f85e9a7-214b-41ae-9bd4-013679f31abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seitz Solution Radial Head Implant System 18 x 9mm Radial Head
• Version Model Number: KCHI-1809
• Catalog Number: KCHI-1809
• Company DUNS: 004171112
• Company Name: Kapp Surgical Instrument Co.
• 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: true
• 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: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com
• Phone: (216) 587-4400
• Email: info@kappsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B033KCHI18090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030237

FDA Product Code

• KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

Sterilization

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

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

[B033KCHI18090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

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• B033KS400240 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 02 - 4in
• B033KS400270 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 02 - 7in
• B033KS400340 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 03 - 4in
• B033KS400370 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 03 - 7in
• B033KS400440 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 04 - 4in
• B033KS400470 - Coned Heparin Needles: 2023-06-22 Coned Heparin Needles – Size 04 - 7in