EAGLE MEDICAL PACKAGING STERILIZATION, INC.

FDA Device Registration & Listing · PASO ROBLES, CA, US · Registration 2028632

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
2028632
FEI Number
1000125025
Entity Name
EAGLE MEDICAL PACKAGING STERILIZATION, INC.
City/State/Country
PASO ROBLES, CA, US
Establishment Address
2921 UNION RD, PASO ROBLES, CA 93446, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
EAGLE MEDICAL, INC. (Owner Number: 9005849)
Owner / Operator Contact Address
2921 UNION RD, SUITE A, --, PASO ROBLES, CA 93446, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K821801
PMA Number
N/A

All Registered Proprietary Names

Acumed Lower Extremity Congruent Plate System INnate Acumed Cannulated Cancellous Bone Screw Octane™ Straight Intervertebral Fusion Device, Ti Coated Octane Straight/IR PEEK Glenoid Resurfacing System Acutrak Plus Fixation System NanoPhix Cannulated Lag Screw System Acutrak Headless Compression Screw Acumed Bone Graft System TigerShark C Acumed Cerclage Crimp Sleeve AcuTie Sternal System Ascendant PEEK Harrier SA Stableloc External Fixator Octane T Acumed Congruent Bone Plate System ToeMotion TigerShark Lateral Threaded Acumed Scapula Congruent Bone Plate Acumed HubCap Wrist Fustin Plate Congruent Bone Plate System Extension Plates Talos L Talos P Talos A Talos T Ziplyft Blepharoplasty kit Acumed Tension Band Pin Unicompartmental Knee Resurfacing Prosthesis depth gauge Acumed Cortical Bone Screw Blackhawk Ti Guide wire Acumed Radius Rod Healthmark Industries Acumed Anatomic Radial Head System Drill Ascendant PC ArcPhix Acumed Small Bone External Fixator Spinal Jaxx Interbody Fusion Device Acumed Polarus Modular Shoulder System Acumed Bone Plate System Orthopedic Manual Surgical instrument INnate Acumed Orthopaedic Osteo-Clage Wires Talos C Norsen Debrider

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-11-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-17
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2014-11-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-03-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-12-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-12-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-17
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2012-12-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-17
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-12-17
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-12-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained Unknown Class U N/A 2014-11-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-12-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-20
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2025-01-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-20
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-11-03
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2023-03-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2024-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-03
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-06-24
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-03-13
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2012-12-20
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2023-06-02
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2012-12-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-03-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2019-12-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-11
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2012-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-02-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2012-12-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-20
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2024-11-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-03-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-17
LRN Wire, Surgical Orthopedic Class 2 888.3030 2012-12-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-12-20
GED Brush, Dermabrasion, Manual General, Plastic Surgery Class 1 878.4800 2020-12-18

Official Correspondent

JODY BIRKS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EAGLE MEDICAL, INC.
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 2028632. Last updated year: 2026. Please use registration number 2028632 when referencing this establishment in official correspondence.
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