FDA Registration
Active
🇺🇸 United States
EPTAM WEST LLC
Reg #: 3011302692
·
FEI: 3011302692
·
Expires 2026
Products
27
Proprietary Names
31
Establishment Types
1
Classifications
27
Registration Details
- Registration Name
- EPTAM WEST LLC
- Registration Number
- 3011302692
- FEI Number
- 3011302692
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 615 Wooten Rd Ste 150
- City
- Colorado Springs
- State
- CO
- ZIP
- 80915
- Country
- US
Owner / Operator
- Firm Name
- EPTAM WEST LLC
- Operator Number
- 10048254
- Address
- 615 Wooten Rd., Suite 150
- City
- Colorado Springs
- State
- CO
- Postal Code
- 80915
- Country
- US
- Correspondent
- Tristan Manus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-04-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-04-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2018-12-17 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2017-04-14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2018-12-17 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2018-12-17 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2017-06-13 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-04-14 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-04-19 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2017-04-19 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2017-04-14 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2017-04-14 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2017-04-14 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2017-04-19 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2018-12-17 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2017-04-19 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-04-14 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-04-14 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2017-04-20 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2017-04-19 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-12-17 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2016-08-11 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2017-04-19 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2014-12-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2017-04-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-04-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-04-19 |
Proprietary Names
HRS - Plate, fixation, bone HWC - Screw, fixation, bone
GEA / CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
JDQ - Cerclage, fixation HRS - Plate, fixation, bone
JDW - PIN, FIXATION, THREADED KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
JEY - PLATE, BONE
HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HWT - TEMPLATE
HWJ / AWL
HTO - REAMER
HRS - Plate, fixation, bone
HTY - PIN, FIXATION, SMOOTH JDN - IMPLANT, FIXATION DEVICE, SPINAL
KTW - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
FZO - CHISEL, SURGICAL, MANUAL
HXC / WRENCH
GDI / DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
HRS / Plate, fixation, bone
HWC - Screw, fixation, bone HTN - WASHER, BOLT NUT
HTN - WASHER, BOLT NUT HWC - Screw, fixation, bone
FTY - TAPE, MEASURING, RULERS AND CALIPERS
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
OSN - Software for diagnosis/treatment KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
OAT - Implant, endosseous, orthodontic
MQV - FILLER, BONE VOID, CALCIUM COMPOUND
DZL - SCREW, FIXATION, INTRAOSSEOUS
PASSER
HXX - SCREWDRIVER
KTT - APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT JDW - PIN, FIXATION, THREADED
FZX - Guide, surgical, instrument
KTT / APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXH / Orthopedic manual surgical instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)