SD800568

GUDID 10887587066271

PSI SD800.568 PEEK IMPLANT

SYNTHES (U.S.A.) LP

Cranial bone prosthesis, custom-made

• Primary Device ID: 10887587066271
• NIH Device Record Key: d158a80e-c2c6-4ced-a0da-9729cd91d289
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD800.568
• Catalog Number: SD800568
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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
• 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
• 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	10887587066271 [Primary]
HIBCC	H980SD8005680 [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

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

[10887587066271]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

• H981PDL432F - NA: 2026-02-09 INLAY PUSHER-MEDIUM
• H981PDL434H - NA: 2026-02-09 INLAY PUSHER-LARGE
• 07611819995796 - NA: 2026-02-09 TAMP
• 07611819943490 - NA: 2026-02-09 HEAD IMPACTOR
• H679E51157P09 - NA: 2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
• 10886982293060 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
• 10886982293237 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
• 10886982293244 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25