Identity
- Trade Name
- MAX VPCSOFT TISSUE GUIDE FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Model / Reference
- 231201425 FDA UDI
Identifiers
- Catalog Number
- 231201425 FDA UDI
- Primary DI / UDI-DI
- 00880304804708 FDA UDI
- 510(k) Number
- K160058 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
Max Vpcsoft Tissue Guide by Biomet Orthopedics, 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
- Titan™ — Ascension Orthopedics, Inc. · Class I
- 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
K160058 also covers:
- MAX VPCCANNULATED DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRIVER HEX AO — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED DRIVER HEX AO — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED PROFILE DRILL — Biomet Orthopedics, Inc.
- MAX VPCCANNULATED PROFILE DRILL — Biomet Orthopedics, Inc.
- MAX VPCK-WIRE — Biomet Orthopedics, Inc.
- MAX VPCVARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc.
- MAX VPCVARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 86337ee9-95ab-4bf1-a1c3-10b5bce6c7e7 36 fields · synced May 30, 2026