T & L SHARPENING, INC.

FDA Device Registration & Listing · Indiana Beach, IN, US · Registration 3003541440

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
3003541440
FEI Number
3003541440
Entity Name
T & L SHARPENING, INC.
City/State/Country
Indiana Beach, IN, US
Establishment Address
2663 S. FREEMAN RD., Indiana Beach, IN 47960, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
T & L SHARPENING, INC. (Owner Number: 9048693)
Owner / Operator Contact Address
2663 S. FREEMAN RD., 2663 S Freeman Road, Monticello, IN 47960, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-10
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-03-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-03-10
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2026-03-10
HWT Template Orthopedic Class 1 888.4800 2013-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-27
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-01-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-01-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-10
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2026-03-10
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2026-03-10
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2026-03-10
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2026-03-10
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-03-10
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-03-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-03-10
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-10
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2026-03-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-10
HTO Reamer Orthopedic Class 1 888.4540 2013-01-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-03-10
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2026-03-10
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2026-03-10
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2026-03-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-05
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-03-10
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-03-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-01-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2015-09-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2026-03-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2026-03-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2026-03-10
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2026-03-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-03-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-03-10

Official Correspondent

Vicki All

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

T & L SHARPENING, 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
K860442 Howmedica Corp. PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 1986-05-06
K973124 Sulzer Orthopedics, Inc. APR POROUS HA HIP SYSTEM 1997-11-03
K201660 Kyocera Medical Technologies, Inc. KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System 2020-07-16
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003541440. Last updated year: 2026. Please use registration number 3003541440 when referencing this establishment in official correspondence.
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