FDA Registration
Active
🇺🇸 United States
MICROPULSE INC
Reg #: 1834379
·
FEI: 1000306303
·
Expires 2026
Products
82
Proprietary Names
155
Establishment Types
2
Classifications
82
Registration Details
- Registration Name
- MICROPULSE INC
- Registration Number
- 1834379
- FEI Number
- 1000306303
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5865 E State Road 14
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Owner / Operator
- Firm Name
- Micropulse
- Operator Number
- 10042100
- Address
- 5865 E State Road 14
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2022-12-21 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-12-21 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-04-03 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-04-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-04-03 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2024-07-12 |
| Sperm, Fitc, Antigen, Antiserum, Control | DFX | Class 1 | Immunology | No | 2013-07-05 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2022-08-19 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-08-19 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2022-08-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2022-08-19 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-01-07 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-01-07 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-06-16 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-02-14 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-12-21 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-08-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2024-08-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-08-22 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-02-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-03-30 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Light, Surgical, Instrument | FSQ | Class 2 | General, Plastic Surgery | No | 2013-01-11 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2013-01-11 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-04-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-12-21 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2013-04-03 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-12-21 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2022-12-21 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2021-02-15 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-02-14 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2012-12-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2026-03-30 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2025-01-29 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-07-19 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2019-06-19 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-06-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-14 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-02-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-02-18 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-02-14 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-08-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-04-03 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-02-14 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-08-15 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-05-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-05-17 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-05-17 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-08-15 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-02-14 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-04-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-14 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-02-14 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-01-05 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-04-03 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2013-04-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-04-03 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-01-05 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-02-14 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-04-16 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-02-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-06-17 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2020-06-17 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2020-06-17 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2020-06-17 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2020-06-17 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2020-06-17 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2014-04-10 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2024-01-31 |
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
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
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
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
TriALTIS Slip Sleeve, Long
TriALTIS Retaining Sleeve, Short
TriALTIS Screwdriver, T27 Cement
TriALTIS Screwdriver, T27 Long Retain
TriALTIS Retaining Sleeve, Cement
TriALTIS Slip Sleeve, Short
TriALTIS Screwdriver, T27 Short Retain
Screwdriver
TriALTIS Screwdriver, T27 Long Cann
TriALTIS Screwdriver, T27 Short Cann
CANNULA
NEXA BONE PLATE AND SCREW SYSTEM
AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Compression Instrument
TRAXIS CEMENT RESTRICTOR
RETRACTOR
PIPELINE LS ANT BLADE 5X115
PIPELINE LS ANT BLADE 5X145
PIPELINE LS ANT BLADE 5X125
PIPELINE LS ANT BLADE 5X105
PIPELINE LS ANT BLADE 5X135
PIPELINE LS ANT BLADE 5X155
INHANCE Reverse Shoulder System
AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT
Bender
Wrench
SAHTRT00 HUMERAL TRAY RIGHT 0MM
SAHTST12 HUM TRAY NEUTRAL +12MM STD
SAHTNE06 HUMERAL TRAY NEUTRAL 6MM
SAHTRTM6 HUMERAL TRAY RIGHT -6MM EXT
SAHTNEM6 HUMERAL TRAY NEUTRAL -6MM EXT
SAHTLT00 HUMERAL TRAY LEFT 0MM
SAHTST00 HUM TRAY NEUTRAL +0MM STD
SAHTLTM6 HUMERAL TRAY LEFT -6MM EXT
SAHTNE12 HUMERAL TRAY NEUTRAL 12MM
SAHTNE00 HUMERAL TRAY NEUTRAL 0MM
SAHTST06 HUM TRAY NEUTRAL +6MM STD
ARDIS INTERBODY SYSTEM
G7 ACETABULAR SYSTEM
LANX FUSION SYSTEM
VIRAGE OCT SPINAL FIXATION SYSTEM
CANNULATED CANCELLOUS BONE SCREW
Univers Revers Modular Glenoid System (Augemented baseplates)
STABLELOC II EXTERNAL FIXATOR
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
ACUMED PELVIC BONE PLATE SYSTEM
V2F ANTERIOR FIXATION SYSTEM
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
Tether Trays
LANX CERVICAL SA
Univers Revers Modular Glenoid System, Standard Augment Baseplates
TriALTIS Retaining Sleeve, Long
TriALTIS Screwdriver, T27 Nav Cann
TriALTIS Screwdriver, T27 Nav
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Reprocess Single-Use Device