Identity
- Trade Name
- 8 Hole Gridlock Helical Plate, Right FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 300-65-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926028507 FDA UDI
- 510(k) Number
- K160177 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
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 fixation plate, non-bioabsorbable, non-sterile
8 Hole Gridlock Helical Plate, Right by Trilliant Surgical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
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- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
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- APTUS — Medartis Inc. · Class II
Cleared under the same submission
K160177 also covers:
- 0.062" x 4.65" Olive Wire Partially Threaded — Trilliant Surgical LLC
- 12 Hole 1/3 Tubular Gridlock Ankle Plate — Trilliant Surgical LLC
- 12 Hole Contoured VL Gridlock Ankle Fibula Plate — Trilliant Surgical LLC
- 2.7mm x 10mm Gridlock Ankle Locking Screw — Trilliant Surgical LLC
- 2.7mm x 10mm Gridlock Ankle Screw — Trilliant Surgical LLC
- 2.7mm x 14mm Gridlock Ankle Locking Screw — Trilliant Surgical LLC
- 2.7mm x 16mm Gridlock Ankle Screw — Trilliant Surgical LLC
- 2.7mm x 22mm Gridlock Ankle Locking Screw — Trilliant Surgical LLC
- 2.7mm x 22mm Gridlock Ankle Screw — Trilliant Surgical LLC
- 2.7mm x 24mm Gridlock Ankle Screw — Trilliant Surgical LLC
- 3.5mm x 10mm Gridlock Ankle Screw — Trilliant Surgical LLC
- 3.5mm x 12mm Gridlock Ankle Locking Screw — 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 d99e8f4b-b8a0-40e9-93ef-e1d5724eb0bd 33 fields · synced May 31, 2026