FDA Registration
Active
🇺🇸 United States
THE ORTHOPAEDIC IMPLANT COMPANY
Reg #: 3008599979
·
FEI: 3008599979
·
Expires 2026
Products
10
Proprietary Names
24
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- THE ORTHOPAEDIC IMPLANT COMPANY
- Registration Number
- 3008599979
- FEI Number
- 3008599979
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 770 Smithridge Dr Ste 400
- City
- Reno
- State
- NV
- ZIP
- 89502
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181184
Owner / Operator
- Firm Name
- The Orthopaedic Implant Company
- Operator Number
- 10033702
- Address
- 770 Smithridge Dr, STE 400
- City
- Reno
- State
- NV
- Postal Code
- 89502
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-07-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2014-06-17 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2014-06-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2011-01-05 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-01-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2012-04-11 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-10-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2012-10-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2021-05-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2010-12-06 |
Proprietary Names
OIC INTRAMEDULLARY NAIL SYSTEM
OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM
OIC CLAVICLE PLATING SYSTEM
OIC DISTAL RADIUS PLATING SYSTEM
OIC PROXIMAL HUMERUS PLATING SYSTEM
OIC DRILL BIT
OIC INTRAMEDULLARY SCREW SYSTEM
OIC SUTURE ANCHOR SYSTEM
OIC CANNULATED SCREW SYSTEM
OIC SLIDING HIP SCREW SYSTEM
OIC DORSAL SPANNING PLATE
OIC CERVICAL CAGE
DRPx Distal Radius Plate System
OIC General Surgical Instruments
OIC Distal Tibia Plates
OIC ANKx System
OIC Proximal Humerus Plates
OIC Proximal Tibia Plates
OIC Clavicle Plates
OIC Olecranon Plates
OIC Locking Small Frag
OIC Small / Mini Fragment Plate System
FlexFix Syndesmosis Repair Kit
OIC EXTERNAL FIXATION SYSTEM
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility