Identity
- Trade Name
- VSP Orthopedics FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Reusable accessory drill guide FDA UDI
- Model / Reference
- Drill Guide (2.7mm and 6.5mm) FDA UDI
- Description
- Reusable accessory drill guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816847022545 FDA UDI
- 510(k) Number
- K190044 FDA UDI
- FDA Product Code
- PBF FDA UDI
- GMDN Term
- Surgical drill guide, reusable 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 drill guide, reusable
VSP Orthopedics by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
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- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
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 e92d5b4a-71df-45f5-ac30-5bd5fca27c08 34 fields · synced May 30, 2026