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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
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides. FDA UDI
Model / Reference
Bone Osteotomy Guide FDA UDI
Description
A physical template that can be positioned at the osteotomy site that allows the physician the ability to precisely drill the bone screw holes that position the implant positioning or osteotomy guides. FDA UDI

Identifiers

Primary DI / UDI-DI
00816847020961 FDA UDI
510(k) Number
K120956 FDA UDI
K133907 FDA UDI
K151285 FDA UDI
K192192 FDA UDI
FDA Product Code
DZJ FDA UDI
LLZ FDA UDI
PPT FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

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 Custom-made orthopaedic/craniofacial surgical guide.

Cleared under the same submission

K120956 also covers:

K133907 also covers:

K151285 also covers:

K192192 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Systems, Inc.

Sources (1)

  • FDA UDI 8e21ecfe-6ba0-43a6-9963-92805b1e3b81 35 fields · synced Jun 1, 2026