Identity
- Trade Name
- VSP Orthopedics FDA UDI
- Generic Name
- Surgical implant template, single-use FDA UDI
- Device Name
- A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. FDA UDI
- Model / Reference
- Orthopedic Bone Osteotomy Template FDA UDI
- Description
- A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816847022552 FDA UDI
- 510(k) Number
- K190044 FDA UDI
- FDA Product Code
- PBF FDA UDI
- GMDN Term
- Surgical implant template, single-use 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: Surgical implant template, single-use
VSP Orthopedics by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, single-use.
- TEMPLATE, STERILE — KLS-Martin L.P. · Class I
- DISTRACTION, INTERNAL, STERILE — KLS-Martin L.P. · Class I
- Ossera™ AFX Instrumentation — Restor3D · Class II
- LEVEL ONE NEURO — KLS-Martin L.P. · Class I
- Ossera™ AFX Instrumentation — Restor3D · Class II
- Ossera™ AFX Instrumentation — Restor3D · Class II
- Ossera™ AFX Instrumentation — Restor3D · Class II
- Ossera™ AFX Instrumentation — Restor3D · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3d Systems, Inc.
Sources (1)
- FDA UDI 88eeec0f-af89-4c89-b28a-e59c918bb72b 34 fields · synced May 31, 2026