Identity
- Trade Name
- 4.0mm x 48mm Gridlock Ankle Screw FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 304-40-048 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926025988 FDA UDI
- 510(k) Number
- K160177 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 48 Millimeter FDA UDIOuter Diameter — 4.0 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
The 4.0mm x 48mm Gridlock Ankle Screw is a non-sterile, non-bioabsorbable orthopaedic bone screw used for internal fixation of fractures or direct interfragmentary stabilization. Made from implant-grade metal materials, it provides stable and secure fixation. This device must be sterilized prior to use. With various screw sizes available (cortical, cancellous, malleolar, scaphoid, partially-threaded, fully-threaded, self-tapping, cannulated), the Gridlock Ankle Screw can be tailored to specific needs.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · 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
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 b8f99917-ad87-46ca-a2cd-ed007fb13ff4 34 fields · synced Jul 10, 2026