FDA Registration
Active
🇺🇸 United States
MEDICAL DEVICE AND IMPLANTS LLC
Reg #: 3009826895
·
FEI: 3009826895
·
Expires 2026
Products
16
Proprietary Names
38
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- MEDICAL DEVICE AND IMPLANTS LLC
- Registration Number
- 3009826895
- FEI Number
- 3009826895
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Medical Device and Implants LLC, 1824 and 1813 Colonial Village Lane
- City
- Lancaster
- State
- PA
- ZIP
- 17601
- Country
- US
Owner / Operator
- Firm Name
- Medical Device and Implants LLC
- Operator Number
- 10042103
- Address
- Medical Device and Implants LLC DBA Spitrex MDI, 1824 and 1813 Colonial Village Lane
- City
- Lancaster
- State
- PA
- Postal Code
- 17601
- Country
- US
- Correspondent
- Donald K Mowry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2022-06-23 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-07-15 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-12-06 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-07-15 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-05-04 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2019-03-04 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2022-07-15 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2022-07-15 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2022-07-15 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2022-07-15 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-01-19 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-06-23 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2022-07-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-07-15 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-07-15 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2022-07-15 |
Proprietary Names
Trauma Integrated Hip System
Geminus Plating System
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple
CoLink Mini
Single/Multiple Component Metallic Bone Fixation Appliances and Accessories
Vilex, Inc.
Smooth or Threaded Metallic Bone Fixation Fastener
Small Bone Nailing System
Reduct Headless Compression Screw System
Trauma Cannulated Fastener
Skeletal Dynamics Humeras Plating System
Skeletal Dynamics Forearm Plating System
STYLOID SCREW (MOD T5 DRIVE) 2 mm X 28mm STYLOID SCREW (MOD T5 DRIVE) 2 mm X 30mm STYLOID SCREW (MOD T5 DRIVE) 2 m
Intervertebral Body Fusion Device
Stabllyx Implant System
Kinos Axiom Total Ankle System
Precise Distal Radial Volar Plate
CORT SCREW LOCKING SELF TAPPING T6 2.7mm X 10mm CORT SCREW LOCKING SELF TAPPING T6 2.7mm X 14mm CORT SCREW LOCKING SELF
Trauma Fasteners
Reference Toe System (RTS)
Tyber Medical Trauma Screw, Headed
RibFix Advantage System
Manticore Anchor System
CoLink Afx Plating System
PROTEAN Fragment Plating System
Tyber Medical Trauma Screw, Headless
Align Radial Head System
Hand Trauma Screw System
Distal Elbow Plating System
Spinal Intervertebral Body Fusion Orthosis
TyFix Screw
Trauma Locking Fastener
Vilex
Lumbar IBFD System
CANNULATED SCREW MEASURING GAGE
CoLink Cfx
CoLink NeoFuse
Skeletal Dynamics USP System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)