Identity
- Trade Name
- Arsenal Foot FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 3.5mm x 26mm Arsenal Locking Screw FDA UDI
- Model / Reference
- 308-35-026 FDA UDI
- Description
- 3.5mm x 26mm Arsenal Locking Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810028391208 FDA UDI
- 510(k) Number
- K191009 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
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 bone screw (non-sliding)
Arsenal Foot by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
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 b761000b-21eb-4351-b8b7-f0fbea0a8093 34 fields · synced May 30, 2026