FDA Registration
Active
🇺🇸 United States
FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower
Reg #: 3009996260
·
FEI: 3009996260
·
Expires 2026
Products
18
Proprietary Names
1
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- FLOWER ORTHOPEDICS CORPORATION DBA Conventus Flower
- Registration Number
- 3009996260
- FEI Number
- 3009996260
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Witmer Rd Ste 280
- City
- Horsham
- State
- PA
- ZIP
- 19044
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132248
Owner / Operator
- Firm Name
- FLOWER ORTHOPEDICS CORPORATION
- Operator Number
- 10044024
- Address
- 100 Witmer Road, Suite 280
- City
- Horsham
- State
- PA
- Postal Code
- 19044
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-05-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-05-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2020-11-29 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2020-05-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-05-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-28 |
| Template | HWT | Class 1 | Orthopedic | No | 2020-05-13 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-05-13 |
| Bender | HXW | Class 1 | Orthopedic | No | 2020-05-13 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-05-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-03-09 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2022-11-23 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2020-05-13 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-05-13 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2020-05-13 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-01-30 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-08-31 |
Proprietary Names
Flex-Thread Distal Fibula Intramedullary Nail System (5.5mm Nail & 1mm End Cap)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198