09405963S

GUDID 07612334213921

RADIAL HEAD W/ Ø19MM HD, Ø6.5MM STM,9(+3)MM HD HT,STER

Synthes GmbH

Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis Elbow radius prosthesis

• Primary Device ID: 07612334213921
• NIH Device Record Key: 648de775-7cdd-4408-9a2f-ece2a458c55d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 09.405.963S
• Catalog Number: 09405963S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334213921 [Direct Marking]
GS1	10886982300560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183618

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

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: 2022-05-02
• Device Publish Date: 2020-06-08

Devices Manufactured by Synthes GmbH

• 10887587078311 - NA: 2024-06-04 PLATE HOLDING FORCEPS WITH BALL AND FOOT
• 10887587078366 - NA: 2024-05-22 BONE PUSHER
• 10886982344229 - NA: 2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
• 10886982344236 - NA: 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344243 - NA: 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
• 10886982346940 - NA: 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA