FDA Registration
Active
🇺🇸 United States
SCT, INC.
Reg #: 2249615
·
FEI: 3001049282
·
Expires 2026
Products
45
Proprietary Names
29
Establishment Types
1
Classifications
45
Registration Details
- Registration Name
- SCT, INC.
- Registration Number
- 2249615
- FEI Number
- 3001049282
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 509 Commerce St
- City
- FRANKLIN LAKES
- State
- NJ
- ZIP
- 07417
- Country
- US
Owner / Operator
- Firm Name
- SCT, INC.
- Operator Number
- 9040558
- Address
- 509 COMMERCE ST., --
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
- Correspondent
- DANIEL - TORTORA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2013-02-25 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2019-08-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-08-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-08-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-08-06 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2013-03-26 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-03-26 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-06-12 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-02-26 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2015-03-09 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2015-03-09 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2015-03-09 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2015-03-09 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2015-03-09 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2015-03-09 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2015-03-09 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2021-02-11 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-02-26 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-03-26 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-05-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-03-26 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2013-03-26 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2013-03-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-03-26 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-03-26 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-03-04 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-02-26 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-03-04 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-02-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-25 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2013-02-26 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-02-26 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-02-26 |
Proprietary Names
ZIMMER BIOMET
MODULAR PROXIMALLY FLUTED HIP STEM
DURACON TOTAL KNEE SYSTEM
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
SMITH & NEPHEW 6.5MM AND 8MM CANNULATED SCREWS
PERI-LOC
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
REDAPT
Knowles Pin
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
Drill Bit
HOWMEDICAL TOTAL KNEE STEM EXTENDER
ZIMMER NEXEL TOTAL ELBOW
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
ILIZAROV
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
MAKO Restoris PST/TFS Instruments; Pipeline Hip Instruments
GENESIS
ZIMMER TRABECULAR METAL TOTAL ANKLE
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
JOURNEY II BCS KNEE SYSTEM
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)