Identity
- Trade Name
- Vilex Plate FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Plate, Lapidus 29mm Flat_Ti Gold FDA UDI
- Model / Reference
- LAP29-F FDA UDI
- Description
- Plate, Lapidus 29mm Flat_Ti Gold FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731108166 FDA UDI
- 510(k) Number
- K041287 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The Vilex Plate is a non-sterile, non-bioabsorbable orthopaedic fixation plate designed to treat traumatic or pathological fractures in long bones. Made from implant-grade metal such as surgical steel, titanium alloy, or carbon fibre, this device is intended for use in orthopedic surgery and temporary augmentation of bone following a lengthening procedure.
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
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Cleared under the same submission
K041287 also covers:
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
- Vilex AVID Plate Screw — Vilex, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Vilex, Inc.
Sources (1)
- FDA UDI b272b34c-6ecb-45d8-b429-1569d67e94fc 34 fields · synced Jul 3, 2026