MICROPULSE INC

FDA Device Registration & Listing · Columbia City, IN, US · Registration 1834379

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
1834379
FEI Number
1000306303
Entity Name
MICROPULSE INC
City/State/Country
Columbia City, IN, US
Establishment Address
5865 E State Road 14, Columbia City, IN 46725, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Micropulse (Owner Number: 10042100)
Owner / Operator Contact Address
5865 E State Road 14, Columbia City, IN 46725, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CoLink Plating System Cutting Instrument Elevator PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES Avenger Radial Head System FITC, ANTIGEN Valkyrie Thoracic Fixation System Comprehensive Shoulder System OPTIO-C ANTERIOR CERVICAL SYSTEM FlareHawk Interbody Fusion System Curette Bone Tap NeoSpan SCREWDRIVER - T27 NAV Navigated EXPEDIUM 5.5 Driver Shaft Navigated EXPEDIUM 5.5 Extended Driver Sleeve RETAINING SLEEVE – LONG Navigated EXPEDIUM 4.5 Driver Shaft Navigated EXPEDIUM 4.5 Driver Sleeve SCREWDRIVER - T27 NAV CANNULATED Navigated EXPEDIUM 5.5 Driver Sleeve Manual Chisel PUNCH WRIST FUSION PLATE Broach ZSFab Cervical Interbody System Surgical File Avenger Radial Head System HyProCure II Positioning Sleeve SPOTLIGHT ACCESS SYSTEM Tamp Rulers and Calipers ACUTRAK PLUS FIXATION SYSTEM SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM BONE PLATE SYSTEM LANX SPINAL FIXATION SYSTEM CATHETER AND TIP OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM LANX LATERAL RTS Lesser ZIMMER NEXEL TOTAL ELBOW Extractor LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) RTS CORTICAL BONE SCREW ZSFab Lumbar Interbody System ACUMED ANATOMIC RADIAL HEAD SYSTEM NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM Cutter BONE SCREW 3.5 MM Hook DISSECTOR LANX FACET SCREW SYSTEM 4.5 and 5.5 NAVIGATION DRIVER - SHAFTS and SLEEVES Inhance 145 Degree Reverse Liner FlareHawk Interbody Fusion System Valkyrie Thoracic Fixation System TightRope II CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE Univers Revers Modular Glenoid System, Half Augment Baseplate OSTEOTOME COMPREHENSIVE PRIMARY SHOULDER STEMS TRAY, SURGICAL, INSTRUMENT CoLink AFx Plating System ACUTE INNOVATIONS STERNAL FIXATION SYSTEM SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM Orthopedic manual surgical instrument TriALTIS Sequential Reducer, Short In TriALTIS Connector Holder TriALTIS Sequential Reducer, Short Out ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Caliper SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM ACUTRACT SLIC SCREW REPAIR SYSTEM Rasp TriALTIS Set Screw Inserter, T27 X Long PROSTHESIS DRIVER TriALTIS Set Screw Tightener, T27 Long TriALTIS Set Screw Inserter, T27 Short TriALTIS Uni. Inserter Body (Connector) TriALTIS Set Screw Inserter, T27 Long DynaBunion Full Custom Non-Sterile Case MiniBunion Instruments Tray DynaForce Staple Instruments Tray Manual General Use Instrument Surgical Guide ZSFab Cervical Interbody System PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM osteo-WEDGE Screw Retainer Sleeve CONGRUENT BONE PLATE SYSTEM LANX ANTERIOR PLATING SYSTEM ARDIS SPACER Depth Gauge HUMERAL HEAD TRIAL KIT 51 - 57mm SCRW EXT LOADING TEMPLATE HUMERAL HEAD TRIAL KIT 38 - 44mm HUMERAL HEAD TRIAL KIT 44 - 51mm Forceps OSS PROXIMAL FEMORALS Ignite Anatomic Shoulder System Impactor EXTREMITY BONE SCREW Probe CONGRUENT BONE PLATE SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-21
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2013-02-14
HTE Elevator General, Plastic Surgery Class 1 878.4800 2013-02-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-04-03
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2024-07-12
DFX Sperm, Fitc, Antigen, Antiserum, Control Immunology Class 1 866.5800 2013-07-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-30
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-08-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-08-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-08-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-08-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-01-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-01-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-16
HTF Curette General, Plastic Surgery Class 1 878.4800 2013-04-03
HWX Tap, Bone Orthopedic Class 1 888.4540 2013-02-14
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-21
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-08-15
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2024-08-15
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-08-15
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2024-08-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-08-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2024-08-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-22
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-04-03
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2013-04-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-04-10
HTQ Broach Orthopedic Class 1 888.4540 2013-02-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-03-30
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-04-03
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2024-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-16
FSQ Light, Surgical, Instrument General, Plastic Surgery Class 2 878.4580 2013-01-11
GZT Retractor, Self-Retaining, For Neurosurgery Neurology Class 2 882.4800 2013-01-11
HXG Tamp Orthopedic Class 1 888.4540 2013-04-03
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2013-04-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-01-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-04-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-21
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2013-04-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-01-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-21
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2022-12-21
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2021-02-15
HWB Extractor Orthopedic Class 1 888.4540 2013-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-21
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2022-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-09-14
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2014-04-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-10-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-10-18
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2013-04-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-04-03
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-04-03
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2012-12-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-06-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-03-30
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2026-03-30
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-03-30
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2026-03-30
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-03-30
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-01-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-04-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-08-09
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2013-02-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-08-15
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2024-08-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-08-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-08-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2024-08-15
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2024-08-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-01-10
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2020-01-10
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2020-01-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-01-10
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-07-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-12-21
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2019-06-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-19
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-06-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-04-03
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-02-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2012-12-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-21
KTZ Caliper Orthopedic Class 1 888.4150 2013-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
HTR Rasp General, Plastic Surgery Class 1 878.4800 2013-02-18
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2013-02-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-08-01
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-02-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-02-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-09-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-01-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-01-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-01-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-04-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-21
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-04-03
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2013-04-03
HWT Template Orthopedic Class 1 888.4800 2013-02-14
HTD Forceps General, Plastic Surgery Class 1 878.4800 2013-02-14
HTO Reamer Orthopedic Class 1 888.4540 2024-08-15
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-05-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-05-17
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-05-17
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-08-15
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-05-02
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-05-02
PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3660 2022-05-02
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2022-05-02
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-05-02
HWA Impactor Orthopedic Class 1 888.4540 2013-02-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-04-10
HXB Probe Orthopedic Class 1 888.4540 2013-04-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Micropulse
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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834379. Last updated year: 2026. Please use registration number 1834379 when referencing this establishment in official correspondence.
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