Identity
- Trade Name
- 25mm x 20mm x 20mm Staple FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable, non-sterile FDA UDI
- Model / Reference
- 500-25-101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926028620 FDA UDI
- 510(k) Number
- K172405 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone staple, non-adjustable, non-sterile
25mm x 20mm x 20mm Staple by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable, non-sterile.
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- Orbitum VI Staple — CPM Medical Consultants, LLC · Class II
- Nitinex Memory Staple — Vilex, Inc. · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- Orbitum VI Staple — CPM Medical Consultants, LLC · Class II
- DynaBridge — FUSION ORTHOPEDICS, LLC · Class II
- VARISATION STAPLEØ 1, 0MM — Biomet Orthopedics, Inc. · Class II
- Nitinex Memory Staple — Vilex, Inc. · Class II
Cleared under the same submission
K172405 also covers:
- 10mm x 10mm x 10mm Staple — Trilliant Surgical LLC
- 12mm x 12mm x 12mm Staple — Trilliant Surgical LLC
- 15mm x 12mm x 12mm Staple — Trilliant Surgical LLC
- 15mm x 15mm x 15mm Staple — Trilliant Surgical LLC
- 18mm x 15mm x 15mm Staple — Trilliant Surgical LLC
- 18mm x 18mm x 18mm Staple — Trilliant Surgical LLC
- 20mm x 20mm x 20mm High Strength Staple — Trilliant Surgical LLC
- 20mm x 20mm x 20mm Staple — Trilliant Surgical LLC
- 8mm x 8mm x 8mm Staple — 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 d4473da6-8bdd-4d06-82e8-7dd78ae0721d 33 fields · synced May 30, 2026