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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 / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes FDA UDI
Model / Reference
Trauma Drilling Guide FDA UDI
Description
A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes FDA UDI

Identifiers

Primary DI / UDI-DI
00816847020688 FDA UDI
510(k) Number
K120956 FDA UDI
K133907 FDA UDI
K151285 FDA UDI
K192192 FDA UDI
FDA Product Code
LLZ FDA UDI
DZJ FDA UDI
PPT FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide 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

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 8f6b3384-fceb-4e76-a008-fa3abceb0241 35 fields · synced May 30, 2026