FDA Registration
Active
🇺🇸 United States
LH MEDICAL CORPORATION
Reg #: 3010057495
·
FEI: 3010057495
·
Expires 2026
Products
59
Proprietary Names
154
Establishment Types
2
Classifications
59
Registration Details
- Registration Name
- LH MEDICAL CORPORATION
- Registration Number
- 3010057495
- FEI Number
- 3010057495
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6932 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- ZIP
- 46804
- Country
- US
Owner / Operator
- Firm Name
- LH Medical Corporation
- Operator Number
- 10042802
- Address
- 6932 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46804
- Country
- US
- Correspondent
- Ty Carpenter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2021-04-01 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2021-04-07 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-12-12 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-12-12 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-01-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-01-13 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-01-13 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-01-13 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-01-27 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-02 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-01-27 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-01-27 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-01-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-01-27 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-07-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-11-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2026-01-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-01-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2026-01-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2026-01-27 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2026-01-27 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2026-01-27 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2017-08-18 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2017-08-18 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-01-27 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2026-01-27 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2026-01-27 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2026-01-27 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-01-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-02 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-02 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2021-04-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2021-04-07 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2026-01-27 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2026-01-27 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-01-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-02 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2026-01-27 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2014-04-09 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-01-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2022-03-25 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2018-06-28 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-01-27 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-01-05 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-01-05 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2018-06-28 |
| Probe | HXB | Class 1 | Orthopedic | No | 2025-07-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-02 |
Proprietary Names
Patella Clamp 00590352000
51-201000 TPRLC COMPL 133 TYPE1 HIGH OFFSET TRUNNION 4-17MM
51-200000 TPRLC COMPL 133 TYPE1 STAND OFFSET TRUNNION 4-17MM
Comprehensive Shoulder
TM Reverse Shoehorn Retractor
Small Angled Knee Retractor
Fuzion 4-In-1 Adpt R
Fuzion 4-In-1 Adpt L
Fuzion Gap Ref Dr Gde
Proximal Prov
Seg Collar Prov
Prov Acet Shell
TM Prov Shell
ZMR OTJ PROXIMAL PROV 36 X 35 STD
ZMR OTJ PROXIMAL PROV 46 X 35 STD
ZMR OTJ PROXIMAL PROV 45 X 78 XL
ZMR OTJ PROXIMAL PROV 40 X 55 STD
ZMR OTJ PROXIMAL PROV 45 X 103 XL
ZMR OTJ PROXIMAL PROV 40 X 83 XL
ZMR OTJ PROXIMAL PROV 40 X 93 XL
ZMR OTJ PROXIMAL PROV 46 X 45 STD
ZMR OTJ PROXIMAL PROV 45 X 83 XL
ZMR OTJ PROXIMAL PROV 40 X 35 STD
ZMR OTJ PROXIMAL PROV 40 X AA- STD
ZMR OTJ PROXIMAL PROV 46 X 55 STD
ZMR OTJ PROXIMAL PROV 45 X 93 XL
ZMR OTJ PROXIMAL PROV
ZMR OTJ PROXIMAL PROV 40 X 78 XL
ZMR OTJ PROXIMAL PROV 36 X AA- STD
ZMR OTJ PROXIMAL PROV 40 X 103 XL
ZMR OTJ PROXIMAL PROV 40 X 45 STD
110024734-00 G7 DM PROV LINER 50MM H
110024727-00 G7 DM PROV LINER 32MM A
110024733-00 G7 DM PROV LINER 46MM G
110024729-00 G7 DM PROV LINER 38MM C
110024731-00 G7 DM PROV LINER 42MM E
110024728-00 G7 DM PROV LINER 36MM B
110024732-00 G7 DM PROV LINER 44MM F
110024730-00 G7 DM PROV LINER 40MM D
110024735-00 G7 DM PROV LINER 54MM I
110024736-00 G7 DM PROV LINER 60MM J
Oblique Provisional Liner
Elevated Provisional Liner
7MM Offset Provisional Liner
PSN POR TIB SIZ PLT Right SZ F
PSN POR TIB SIZ PLT Right SZ J
PSN POR TIB SIZ PLT Left SZ D
PSN POR TIB SIZ PLT Left SZ E
PSN POR TIB SIZ PLT Right SZ E
PSN LKNG TIB Impactor Pad E-F
PSN POR TIB Drill Guide
PSN POR TIB SIZ PLT Left SZ F
PSN POR TIB SIZ PLT Left SZ G
PSN POR TIB SIZ PLT Right SZ G
PSN POR TIB SIZ PLT Right SZ C
PSN LKNG TIB Impactor Pad G-J
PSN POR TIB SIZ PLT Left SZ C
PSN POR TIB SIZ PLT Left SZ J
PSN POR TIB SIZ PLT Right SZ D
6MM CANNULATED DRILLS
CORTEX DRILLS, 7.5MM
ANATOMICAL SHOULDER TM COMBINED SYSTEM
Provisional Locking Screw
Tap Guide 6.5mmDia
Nexgen Pat Drill Gde Sz38 41mm
Nexgen Pat Drill Gde Sz26 29mm
Drill Guide
Mini Im Alignment Guide - Short
Tap Guide 4.5mmDia
Nexgen Pat Drill Gde Sz32 35mm
Mini Im Alignment Guide - Long
LCCK 6 Deg Dist Fem Gde
RH Knee Condylar Trephine Gde
3 Deg Capt/Uncapt Cutting Head
PFJ Milling Guide
Distal Femoral Resection Guide
Femoral Valgus Alignment Guide
0 Deg Capt/Uncapt Cutting Head
Rev Block Cutter 5, 10, 15, 20
Fem Cut Guide
Tibial Cut Guide
Reflection Constrained Liner 0 Degree 28MM Inner Diameter 58-60MM Outer Diameter Size G Catalog # 71323126
Seg Prov Slaphammer Adaptor
Replacement Impactor Pad
TM Tibial Impactor
Seg Implant Slaphammer Adaptor
Zimmer Trabecular Metal Total Ankle
Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems
Zimmer Persona Knee System
Pectus Blu Support Bars
51-200001 TPRLC COMPL 133 TYPE1 STAN OFFSET TRUNNION 18-24MM
51-201001 TPRLC COMPL 133 TYPE1 HIGH OFFSET TRUNNION 18-24MM
00-8832-005-22 Elevated Provisional Liner
00-8832-019-32 Elevated Provisional Liner
Axle
Zimmer Segment System Trabecular Metal Proximal Tibial Component Trabecular Metal Proximal Component Additional Segmen
Constrained Provisional Liner
Kinectiv Stem Extractor
Offset Sizing Plate Handle
ASI Femoral Head Power Corkscrew
Liner Introduction Frame
Distal Cut Guide
Femoral IM Rod
Femoral Impactor
LCCK 4-N-1 9-10mm Bushing
Cup Inserter Adapter
LCCK STR/OFS Bushing Adapter
LCCK 18mm Bushing
N-K FLX Tibial Inserter
Bonehook
Single Point HB Remover
Liner Introduction Inner Shaft
Modular (T) Handle
Fortex Pedicle Screw System
Neutral Provisional Liner
Axle-X spinous fusion system
Bigliani / Flatow (R) The Complete Shoulder Solution
K-Wires
Certex
Non-Mod Scrdrvr 3.5mm Hex
U-Joint 3.5mm Hex Shaft
Straight 3.5mm Hex Shaft
406997 Comprehensive Humeral Stem Extractor
Zimmer Nexel Total Elbow
Capless Pedicle Screw System
81114193 Spectron EF 12/14 Long Straight Trial Neck Small
81114194 Spectron EF 12/14 Long Straight Trial Neck Medium/Large
Xpress, Fortex
Zimmer Trabecular Metal Reverse Shoulder System, Base Plates and Humeral Stems
Persona Revision Knee System Stems and Augments
Reamer
Pedicle Probe Double Ended
CLS Brevius Stem with Kinectiv Technology
Persona Revision Knee System
Macro ASI NO 1 Hohman Retractor SF
ASI NO 4 Post Acetabular Retractor SF
ASI Retractor Handle Extender
Macro ASI NO 3 Acetabular Retractor SF
ASI NO 1 Hohmann Retractor SF
ASI NO 2 Blunt Cobra Retractor SF
ASI NO 5 Fem Elevator Retractor SF
ASI NO 3 Acetabular Retractor SF
ASI NO 7 SML Hohman Retractor SF
Macro ASI NO 2 Cobra Retractor SF
ASI NO 6 Med Calcar Retractor SF
Post Collateral Retractor, SM
Collateral Retractor
Dual Z Retractor
Collateral Soft Tissue Protect
PCL Retractor
Elevated Provisional Liner (export only)
Oblique Provisional Liner (export only)
Neutral Provisional Liner (export only)
7mm Offset Provisional Liner (export only)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only