SD420509

GUDID H980SD42050907

PSI SD420.509 TITANIUM IMPLANT

Synthes GmbH

Custom-made cranial bone prosthesis

• Primary Device ID: H980SD42050907
• NIH Device Record Key: e4b153f7-5961-40c1-be69-9882d5e4881a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD420.509
• Catalog Number: SD420509
• 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	10887587074917 [Primary]
HIBCC	H980SD42050907 [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

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

Moist Heat or Steam Sterilization

[H980SD42050907]

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

• 10886982349095 - NA: 2025-03-06 PLATE HOLDING FORCEPS LEFT FLARED TIPS
• 10886982349101 - NA: 2025-03-06 PLATE HOLDING FORCEPS RIGHT FLARED TIPS
• 10886982348265 - NA: 2025-03-05 XL IM REDUCTION TOOL CURVED WITH AO REAMER COUPLING
• 10887587078427 - NA: 2025-02-28 1.85MM ORTHOGNATHIC TAP
• 10886982344410 - NA: 2025-02-26 MAXFRAME CONTROL BOX TEMPLATE
• 10886982348333 - NA: 2025-02-26 1.1MM PARALLEL WIRE GUIDE
• 10886982348364 - NA: 2025-02-26 1.4MM PARALLEL WIRE GUIDE
• 10886982348395 - NA: 2025-02-26 1.6MM PARALLEL WIRE GUIDE