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: Osteotomy guide, reusable FDA UDI
Device Name: Reusable accessory Cutting insert FDA UDI
Model / Reference: Metal Slot (35mm) FDA UDI
Description: Reusable accessory Cutting insert FDA UDI

Identifiers

Primary DI / UDI-DI: 00816847021340 FDA UDI
FDA Product Code: DZJ FDA UDI
LLZ FDA UDI
PPT FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Dimensions & Sizes

Size: Length — 35 Millimeter FDA UDI

Category: Osteotomy guide, reusable

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

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: 3d Systems, Inc.

Sources (1)

FDA UDI ef03dbab-dd73-4a01-ab8c-6359c2b26697 35 fields · synced Jun 8, 2026