Identity
- Trade Name
- VERUM Foot System Bone Plate FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- PF5070 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806390858151 FDA UDI
- 510(k) Number
- K131311 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
A comprehensive orthopaedic fixation plate used to treat traumatic/pathological fractures, fuse a joint (arthrodesis), and as part of an osteotomy. Learn more about this innovative device.
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K131311 also covers:
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- Summa Orthopaedics Hand System Bone Plate — Jeil Medical Corporation
- Summa Orthopaedics Hand System Bone Plate — Jeil Medical Corporation
- Summa Orthopaedics System Bone Screw — Jeil Medical Corporation
- Summa Orthopaedics System Bone Screw — Jeil Medical Corporation
- Summa Orthopaedics System Bone Screw — Jeil Medical Corporation
- Summa Orthopaedics System Bone Screw — Jeil Medical Corporation
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
- Jeil Medical Corporation
Sources (1)
- FDA UDI f9d057af-5d38-4886-b866-0848fdb49a43 33 fields · synced Oct 7, 2026