Identity
- Trade Name
- 3.0mm x 38mm Gridlock Locking Screw FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 302-30-038 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812926023410 FDA UDI
- 510(k) Number
- K130964 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
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
Dimensions & Sizes
- Size
- Length — 38 Millimeter FDA UDIOuter Diameter — 3.0 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
The 3.0mm x 38mm Gridlock Locking Screw is a non-sterile, internal orthopaedic fracture fixation device used for holding plates or nails to bone or providing direct interfragmentary stabilization of bone in the context of orthopedic surgeries.
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
K130964 also covers:
- 0.062" x 4.5" Olive Wire Partially Threaded — Trilliant Surgical LLC
- 12mm Evans Plate — Trilliant Surgical LLC
- 2.4mm x 10mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 10mm Gridlock Screw — Trilliant Surgical LLC
- 2.4mm x 12mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 14mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 14mm Gridlock Screw — Trilliant Surgical LLC
- 2.4mm x 16mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 22mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 22mm Gridlock Screw — Trilliant Surgical LLC
- 2.4mm x 34mm Gridlock Locking Screw — Trilliant Surgical LLC
- 2.4mm x 34mm Gridlock 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 3e9eb981-5018-484f-a0f8-217620a12699 34 fields · synced Aug 3, 2026