FDA Registration
Active
🇺🇸 United States
Palm Grip Axial Handle
Reg #: 1064129
·
FEI: 3002684506
·
Expires 2025
Products
1
Proprietary Names
43
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Orthopedic Designs North America, Inc.
- Registration Number
- 1064129
- FEI Number
- 3002684506
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5912 Breckenridge Parkway, Suite F
- City
- Tampa
- State
- FL
- ZIP
- 33610
- Country
- US
Owner / Operator
- Firm Name
- Orthopedic Designs North America, Inc.
- Operator Number
- 10031399
- Address
- 5912 Breckenridge Parkway, Suite F
- City
- Tampa
- State
- FL
- Postal Code
- 33610
- Country
- US
- Correspondent
- Robin A Wilson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-12-20 |
Proprietary Names
Palm Grip Axial Handle
Ratcheting Axial Handle
Guide Wire Introducer
Lag Alignment Plug
Guide Wires (Trocar, Threaded, Round, Ball Tip - 280mm, 500mm, 600mm & 900mm)
Lag Drill
Lag Talon Retractor Driver
Lag Guide Pin (550mm & 800mm)
Lag Talon Deployment Driver
Lag Guide Sleeve
Torque Limiting Handle
Tissue Protector
Lag Drill Stop
Guide Wire Obturator
Lag Driver Connector Screw
T-Handle Pin Puller
Lag Guide Pin Obturator
Ball Tip Sheathed Guide Wire (600mm & 900mm)
Guide Wire Pusher
Nail Talon Driver
Hex Driver 5 & 7mm
Lag Driver
Exchange Tube
Slotted Slap Hammer
Nail-Handle Connector Screw
Handle-Arm Connector Screw
Guide Handle
Screw Sleeve
Drill Sleeve
Trocar
T25 Driver
Slide Hammer
Talon Driver
Handle-Arm Screw
Driver Connector Screw
Lag Guide Pin Placement Aid
Compression Nut Driver
Dual End Drill Guide
Retractor Driver
Flex Anchor Retraction Driver
Flex Anchor Deployment Driver
Driver Shaft
Guide Arm Lock
Establishment Types
Manufacture Medical Device