SD800538

GUDID 10887587065977

PSI SD800.538 PEEK IMPLANT

SYNTHES (U.S.A.) LP

Cranial bone prosthesis, custom-made Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis

• Primary Device ID: 10887587065977
• NIH Device Record Key: 10db1e62-2163-418d-ad3c-df6c28eea7ba
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD800.538
• Catalog Number: SD800538
• 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	10887587065977 [Primary]
HIBCC	H980SD8005380 [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

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

Moist Heat or Steam Sterilization

[10887587065977]

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

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• H679022221160 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/16MM
• H679022221180 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/18MM
• H679022221200 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/20MM
• H679022221220 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/22MM
• H679022221240 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/24MM
• H679022221260 - NA: 2024-02-27 5.0MM VA LOCKING SCREW SLF-TPNG W/T25 STARDRIVE/26MM