Identity
- Trade Name
- Arsenal Foot FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Arsenal 5 Hole VLC Plate FDA UDI
- Model / Reference
- 300-80-005 FDA UDI
- Description
- Arsenal 5 Hole VLC Plate FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926029986 FDA UDI
- 510(k) Number
- K191009 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Arsenal Foot by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191009 also covers:
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
- Arsenal Foot — Trilliant Surgical LLC
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
- Trilliant Surgical LLC
Sources (1)
- FDA UDI 56ac1142-d991-43e1-82cc-d641e1d250c4 34 fields · synced May 30, 2026