VSP System, VSP Cranial

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name: VSP System, VSP Cranial FDA UDI
Generic Name: Surgical implant template, single-use FDA UDI
Device Name: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. FDA UDI
Model / Reference: Bone Graft Template FDA UDI
Description: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants. FDA UDI

Identifiers

Primary DI / UDI-DI: 00816847021272 FDA UDI
510(k) Number: K120956 FDA UDI
K133907 FDA UDI
K151285 FDA UDI
K192192 FDA UDI
K210347 FDA UDI
FDA Product Code: LLZ FDA UDI
DZJ FDA UDI
PPT FDA UDI
GMDN Term: Surgical implant template, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
872.4120 FDA UDI
882.4310 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Surgical implant template, single-use

VSP System, VSP Cranial by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical implant template, single-use.

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Ossera™ AFX Instrumentation — Restor3D · Class II
Ossera™ AFX Instrumentation — Restor3D · Class II

Cleared under the same submission

K120956 also covers:

K133907 also covers:

K192192 also covers:

K210347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: 3d Systems, Inc.

Sources (1)

FDA UDI fd7bf0b2-fc6f-4ba6-9c59-879ca3d468de 35 fields · synced May 30, 2026