Identity
- Trade Name
- VSP Orthopedics FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. FDA UDI
- Model / Reference
- Allograft Tibia Drilling Guide FDA UDI
- Description
- A physical guide that is composed of allograft bony anatomy and allows for precise location of predetermined osteotomy planes and holes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816847021869 FDA UDI
- 510(k) Number
- K190044 FDA UDI
- FDA Product Code
- PBF FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Custom-made orthopaedic/craniofacial surgical guide
VSP Orthopedics by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190044 also covers:
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
- VSP Orthopedics — 3D SYSTEMS, INC.
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 303c0eb4-77c7-4abd-8d9a-683a5157c458 34 fields · synced Jun 1, 2026