SD420521

GUDID H980SD42052101

PSI SD420.521 TITANIUM IMPLANT

Synthes GmbH

Custom-made cranial bone prosthesis

• Primary Device ID: H980SD42052101
• NIH Device Record Key: dc0a8928-6246-42db-9602-c5e6a64d9c8b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD420.521
• Catalog Number: SD420521
• 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	10887587074993 [Primary]
HIBCC	H980SD42052101 [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

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

Moist Heat or Steam Sterilization

[H980SD42052101]

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

• 07612334270139 - EXPert Nail: 2025-10-02 TRAY F/TIBIAL NAIL EX SP INSTR
• H679310930 - NA: 2025-10-01 SMALL CHUCK WITH KEY
• 10886982350190 - NA: 2025-09-22 2.0MM STRAIGHT PLATE 20 HOLES
• 10887587078465 - NA: 2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
• 10886982349873 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 16MM
• 10886982349880 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 18MM
• 10886982349897 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 20MM
• 10886982349903 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 22MM