Identity
- Trade Name
- DVR WRISTRADIAL STYLOID PLATE, WIDE ANATOMY LEFT FDA UDI
- Generic Name
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial FDA UDI
- Model / Reference
- 811828160 FDA UDI
Identifiers
- Catalog Number
- 811828160 FDA UDI
- Primary DI / UDI-DI
- 00887868129421 FDA UDI
- 510(k) Number
- K140622 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial 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
Yes
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
Category: Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
Dvr Wristradial Styloid Plate, Wide Anatomy Left by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial.
- Opteryx® — Innovasis, Inc. · Class II
- PRIMA Proximal Femur Locking Plate System — WISHBONE MEDICAL INC. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- Procedure Kit, Straight Compression Plate, 6 hole with 2.7mm Instruments, Ti — WISHBONE MEDICAL INC. · Class II
- Malleolar Procedure Kit — WISHBONE MEDICAL INC. · Class II
- Opteryx® — Innovasis, Inc. · Class II
- OsteoMed — Osteomed Corp. · Class II
Cleared under the same submission
K140622 also covers:
- DVR WRISTDORSAL PLATE, STANDARD ANATOMY LEFT — Biomet Orthopedics, Inc.
- DVR WRISTDORSAL PLATE, STANDARD ANATOMY RIGHT — Biomet Orthopedics, Inc.
- DVR WRISTDORSAL PLATE, WIDE ANATOMY LEFT — Biomet Orthopedics, Inc.
- DVR WRISTDORSAL PLATE, WIDE ANATOMY RIGHT — Biomet Orthopedics, Inc.
- DVR WRISTRADIAL STYLOID PLATE, STANDARD ANATOMY LEFT — Biomet Orthopedics, Inc.
- DVR WRISTRADIAL STYLOID PLATE, STANDARD ANATOMY RIGHT — Biomet Orthopedics, Inc.
- DVR WRISTRADIAL STYLOID PLATE, WIDE ANATOMY RIGHT — Biomet Orthopedics, Inc.
- DVR WRISTULNA PLATE, BILATERAL — Biomet Orthopedics, Inc.
- DVR®DORSAL PLATE — Biomet Orthopedics, Inc.
- DVR®DORSAL PLATE — Biomet Orthopedics, Inc.
- DVR®RADIAL STYLOID PLATE — Biomet Orthopedics, Inc.
- DVR®RADIAL STYLOID PLATE — 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 1d5ec790-5f92-48ac-ba87-fdf6453cec62 36 fields · synced Jun 8, 2026