EPTAM WEST LLC

FDA Device Registration & Listing · Colorado Springs, CO, US · Registration 3011302692

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011302692
FEI Number
3011302692
Entity Name
EPTAM WEST LLC
City/State/Country
Colorado Springs, CO, US
Establishment Address
615 Wooten Rd Ste 150, Colorado Springs, CO 80915, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EPTAM WEST LLC (Owner Number: 10048254)
Owner / Operator Contact Address
615 Wooten Rd., Suite 150, Colorado Springs, CO 80915, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES 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 JEY - PLATE, BONE FZO - CHISEL, SURGICAL, MANUAL HXC / WRENCH GDI / DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY JEY - PLATE, BONE 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 HWJ / AWL JEY - PLATE, BONE MQV - FILLER, BONE VOID, CALCIUM COMPOUND DZL - SCREW, FIXATION, INTRAOSSEOUS PASSER HXX - SCREWDRIVER HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-04-19
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-17
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2017-04-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-04-14
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-17
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-12-17
JEY Plate, Bone Dental Class 2 872.4760 2017-06-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-04-14
HWT Template Orthopedic Class 1 888.4800 2017-04-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-08-24
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-12-17
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-12-17
HTO Reamer Orthopedic Class 1 888.4540 2017-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-06-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-04-14
JDN Implant, Fixation Device, Spinal Orthopedic Class 2 888.3060 2017-04-14
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2017-04-14
JEY Plate, Bone Dental Class 2 872.4760 2017-04-14
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2017-04-19
HXC Wrench Orthopedic Class 1 888.4540 2018-12-17
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-04-19
JEY Plate, Bone Dental Class 2 872.4760 2017-04-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-04-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-14
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-04-14
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-04-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-04-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2017-04-14
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2016-04-13
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2017-04-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-04-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-04-14
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2017-04-19
HWJ Awl Orthopedic Class 1 888.4540 2018-12-17
JEY Plate, Bone Dental Class 2 872.4760 2017-04-14
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2016-08-11
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2017-04-19
HWQ Passer Orthopedic Class 1 888.4540 2014-12-20
HXX Screwdriver Orthopedic Class 1 888.4540 2017-04-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2017-04-21

Official Correspondent

Tristan Manus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPTAM WEST LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011302692. Last updated year: 2026. Please use registration number 3011302692 when referencing this establishment in official correspondence.
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