GRIDLOCK PLATING SYSTEM
FDA 510(k) clearance K121452 · decided 2012-08-20
Clearance details
- K-number
- K121452
- Device name
- GRIDLOCK PLATING SYSTEM
- Applicant
- Trilliant Surgical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-16
- Decision date
- 2012-08-20
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002 recall (Z-2738-2015) | Trilliant Surgical Ltd. | 2015-09-04 |
| 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL recall (Z-2490-2015) | Trilliant Surgical Ltd. | 2015-08-31 |
| Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concav recall (Z-2456-2015) | Trilliant Surgical Ltd. | 2015-08-24 |