FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
FDA 510(k) clearance K133930 · decided 2014-03-27
Clearance details
- K-number
- K133930
- Device name
- FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
- Applicant
- Flower Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2013-12-23
- Decision date
- 2014-03-27
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended recall (Z-2782-2020) | Flower Orthopedics Corporation | 2020-08-12 |
| Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended recall (Z-2783-2020) | Flower Orthopedics Corporation | 2020-08-12 |
| Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended recall (Z-2784-2020) | Flower Orthopedics Corporation | 2020-08-12 |
| Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended recall (Z-2785-2020) | Flower Orthopedics Corporation | 2020-08-12 |
| Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intende recall (Z-2786-2020) | Flower Orthopedics Corporation | 2020-08-12 |
| Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended recall (Z-2787-2020) | Flower Orthopedics Corporation | 2020-08-12 |