Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010057495

FEI Number

3010057495

Entity Name

LH MEDICAL CORPORATION

City/State/Country

Fort Wayne, IN, US

Establishment Address

6932 Gettysburg Pike, Fort Wayne, IN 46804, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LH Medical Corporation (Owner Number: 10042802)

Owner / Operator Contact Address

6932 Gettysburg Pike, Fort Wayne, IN 46804, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 51-201000 TPRLC COMPL 133 TYPE1 HIGH OFFSET TRUNNION 4-17MM 51-201001 TPRLC COMPL 133 TYPE1 HIGH OFFSET TRUNNION 18-24MM 51-200000 TPRLC COMPL 133 TYPE1 STAND OFFSET TRUNNION 4-17MM 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 Provisional Locking Screw 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 Certex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2021-04-01
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2021-04-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-04-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-04-07
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2021-04-07
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-04-07
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2021-04-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-12-12
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-12-12
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-01-13
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2020-01-13
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-13
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-01-13
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-27
HWT	Template	Orthopedic	Class 1	888.4800	2013-01-02
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-27
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2019-07-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2019-07-26
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2019-07-26
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2019-07-26
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2019-07-26
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-02-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2022-02-07
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2022-02-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-02-07
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-01-27
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-02-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-11-08
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-27
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-27
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-02
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-02
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-01-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-08-18
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3350	2017-08-18
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2017-08-18
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2017-08-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2017-08-18
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2017-08-18
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-01-27
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-01-27
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-02
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-11-01
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-27
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2013-01-02
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2026-01-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2026-01-27
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2018-06-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2018-06-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-06-28
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-01-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-03-20
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-03-22
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-01-27
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2021-04-07
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2021-04-07
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-07
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2021-04-07
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2021-04-07
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-07
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2021-04-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2021-04-07
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-04-07
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2021-04-07
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Orthopedic	Class 2	888.3353	2021-04-07
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-06-13
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-06-13
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-06-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-04-11
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-01-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2026-01-27
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-01-13
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2013-01-02
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-01-02
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2013-01-02
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-01-02
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-01-02
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2013-01-02
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-01-02
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-01-02
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2017-02-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-02
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2026-01-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-03-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-03-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-01-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-09-15
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-09-15
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-02-07
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-04-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2013-01-02
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-02
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2022-01-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-04-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-01-13
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-27
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-27
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-27
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-27
HWB	Extractor	Orthopedic	Class 1	888.4540	2022-03-25
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2018-06-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2019-12-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-01-27
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-09-15
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2014-09-15
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2014-04-11
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2014-04-11

Official Correspondent

Ty Carpenter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LH Medical Corporation

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
K201660	Kyocera Medical Technologies, Inc.	KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System	2020-07-16
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K972928	Howmedica, Inc.	KERBOULL CROSS	1997-11-03
K830313	Biomet, Inc.	CFE TOTAL HIP FEMORAL COMPONENT	1983-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2019	Exactech, Inc.	2	Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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3009973336	Engineered Medical Systems, LLC	Bartlett, TN, US
3015384437	Care Surgical Limited	Burscough Lancashire, GB
2027754	OSTEOMED	ADDISON, TX, US
3005031160	Xtant Medical Holdings, Inc.	Belgrade, MT, US
1932668	MOLDED PRODUCTS INC.	HARLAN, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010057495. Last updated year: 2026. Please use registration number 3010057495 when referencing this establishment in official correspondence.