VSP PEEK

GUDID 00816847022675

to fill a bony void or defect area in the cranial skeleton of patients

3D SYSTEMS, INC.

Cranioplasty plate, non-alterable

• Primary Device ID: 00816847022675
• NIH Device Record Key: 26dea560-1be1-4802-a60c-4a4f71e78a06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSP PEEK
• Version Model Number: Cranial Implant
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847022675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231834

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

Sterilization

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

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

[00816847022675]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-20
• Device Publish Date: 2024-09-12

Devices Manufactured by 3D SYSTEMS, INC.

• 00816847022736 - Salto Talaris Flat Cut Total Ankle System: 2025-01-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022743 - Salto Talaris Flat Cut Total Ankle System: 2025-01-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022750 - Salto Talaris Flat Cut Total Ankle System: 2025-01-20 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the s
• 00816847022767 - Cadence Flat Cut Total Ankle System: 2025-01-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022774 - Cadence Flat Cut Total Ankle System: 2025-01-20 A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes an
• 00816847022781 - Cadence Flat Cut Total Ankle System: 2025-01-20 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the s
• 00816847022637 - Cadence Chamfer Cut Total Ankle System: 2024-09-20 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the s
• 00816847022651 - Salto Talaris Chamfer Cut Total Ankle System: 2024-09-20 A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the s