HOOSIER, INC.

FDA Device Registration & Listing · Corona, CA, US · Registration 2032093

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
2032093
FEI Number
3003058119
Entity Name
HOOSIER, INC.
City/State/Country
Corona, CA, US
Establishment Address
1140 California Ave, Corona, CA 92881, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HOOSIER, INC. (Owner Number: 9041670)
Owner / Operator Contact Address
1140 California Ave, --, Corona, CA 92881, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SJF IFDIFC OMSI OVEIFDIFC2 AFSIB KWQAFSIB3 JDQCF SCRDRI MQPSVBRD2 KWQAFSIB2 MAXIFDBGL PKPFSCUPCPP OVDMQP2 AFSIOSPF AFSI SVBRD IFDBGC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2013-01-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2014-10-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-10
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-10-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-10
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2013-01-10
HXX Screwdriver Orthopedic Class 1 888.4540 2014-10-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-10
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-03-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-10
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-10-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-10-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-10-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-10-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-10-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-10-27
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-10-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-10-27

Official Correspondent

Mitchell McCall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOOSIER, 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
K213667 SI-BONE, Inc. iFuse-TORQ® Implant System 2022-06-10
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K874919 Orthomet, Inc. ORTHOMET WIRE FOR SUTURE, CERCLAGE 1988-01-07
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032093. Last updated year: 2026. Please use registration number 2032093 when referencing this establishment in official correspondence.
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