SD420422

GUDID H980SD42042201

PSI SD420.422 TITANIUM IMPLANT

Synthes GmbH

Custom-made cranial bone prosthesis

• Primary Device ID: H980SD42042201
• NIH Device Record Key: e409da44-a895-4f96-8689-81f06de94307
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD420.422
• Catalog Number: SD420422
• 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: 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: +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	10887587074702 [Primary]
HIBCC	H980SD42042201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033868

FDA Product Code

• GXN: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Sterilization

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

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

[H980SD42042201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by Synthes GmbH

• 10886982350435 - NA: 2026-02-19 HALF BENNETT SMALL/LEFT
• 10886982350442 - NA: 2026-02-19 HALF BENNETT SMALL/RIGHT
• 10886982350459 - NA: 2026-02-19 HALF BENNETT LARGE/LEFT
• 10886982350466 - NA: 2026-02-19 HALF BENNETT LARGE/RIGHT
• 10886982351579 - NA: 2026-02-19 SHOULDER HOOK 2.2 MM TIP / 235 MM LENGTH
• 10886982351661 - NA: 2026-02-19 T-HANDLE AO CONNECTOR
• 10886982351678 - NA: 2026-02-19 T-HANDLE LARGE AO CONNECTOR
• 10886982361288 - NA: 2026-02-19 5MM AWL, QC