MEDTECH LLC

FDA Device Registration & Listing · Millington, TN, US · Registration 3010123256

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
3010123256
FEI Number
3010123256
Entity Name
MEDTECH LLC
City/State/Country
Millington, TN, US
Establishment Address
8022 Martha Rd, Millington, TN 38053, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MedTech-LLC (Owner Number: 10043432)
Owner / Operator Contact Address
8022 Martha road, Millington, TN 38053, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

XXcm DL Medial/Lateral Blade Longitudinal Blade Distractor Frame Clamp Threaded Probe 4.5 x 40mm Awl Lapidus Nail, Tissue Protector Assembly Straight Shaft Cup Inserter Intramedullary Rod Distractor Pin Driver 14X40 Long Tooth Disc Blade General Tissue Protector, Jones Screw Curved Anterior Spreader Narrow 90 Deg Compressor-Small Angled Blade Adaptor, Left Distractor Tip, 13mm MIS Tibial Cut Block - Left- Frog Eyes 5.5 Rod Pusher Instrument, 2mm Wire, 4 in length 5.5 Depth Gage Lateral Column Fusion Modular Distrator Tip, 30mm, LH Distal Femoral Cut Guide, Fixed ,5 Deg Blade, Wide, Toothless, Curved, 30L X XXW Head Adjuster with Silicone Handle Tibial Sizer Size 3 Tibial Sizer Size 4 TL Blade-Long Tibial Insert Trial, PS-Max; Size 3 Gorilla, R3con, Drill Guide, Centering In-Line Distractor, QC, 7.5mm Wide Instrument, STROPP, 2.8mm Pin 6.35 Provisional Driver 8mm Bullet Distractor 14mm Working Channel Syndesmosis Depth Gage Ratch, Ultra Mini Axial Pull A-O, Spin Cap Tibial Broach Assembly SZ 3-4 Femoral Trial Size 3 Driver Shaft General SS Adjustable Cobb Tibial Insert Trial, PS-Max; Size 6 14mm Fixed Discectomy Blade, XXmm Long Blade Retractor TL XXmm LH Plate Cutter, Double Action 230mm, Straight Depth Gage, 50mm Universal Inserter, Assembly Calcar Planer MIS Tibial Cut Block - Right - Frog Eyes Evans Wedge Trial Size 6/8 Malleable Guard - Medium 5x14x11 Drill Guide Trial 14mm Dia Modular Distractor Shaft Extra Wide Discectomy Blade XXmm X 40mm 10/20mm Distractor Tip Biopsy Drill Retractor 10mm Inserter Slap Hammer Articulating Distractor LH 6mm x 22mm Cobb Distractor AP sizer T27 Screwdriver with T-Handle Distractor Tip, 11mm 5.5/6 Distractor Pin 25/50mm Tibial Stem Ream Guide Lapidus Nail Locking Guide 2.8mm, 0 Degree Graft Stamp Die Plate Precut Angled Blade Adaptor, Right OLIF Round Blade Caudad, Cephalad Patella Planer, 37mm 16mm Discectomy Blade Tibial Sizer Size 2 Alignment Rod TL Blade-Disc General 20mm x XXmm Longitudinal Blade Dilator Inner Shaft Dilator 24.8mm 5mm Distractor Femoral Cutting Block In-Line Distractor, QC, 9.5mm Wide Shaver 6mm Disc Spreader Vertebral Body Alignment Tool 5.5/6 Distactor Pin Precision Guide, NC-Fusion Left TSRH-RP Offset Screwdriver Modular Distrator Tip, 35mm, RH 16mm Left Half Tube 6.35 Provisional Driver, Short 8/8mm Distractor Tip ARC Mill Bushing-Body 3.5mm Skinny Metal Screwdriver 2.3mm, 10 Degree Hammertoe Stamp Cutting Die Precut Distractor w/90 Degree Handles Hand Tamp 8mm Straight Distractor 8 Deg Modular Broach Holder Straight Compressor Distractor 5.5 Long Laminar Spreader Low Profile DL Blade, Right 10/18mm Distractor Tip 13mm Disc Shaver 8/10mm Distractor Tip Can Opener ACDF Pin Distractor Femoral Stem Hoop Extractor 16x13 Rasp Bone Funnel, Tamp Gorilla, Mini Plate Bender, Threaded Bending Bar 5.5/6 TLIF/PLIF Distractor with Extended Rack 20mm Dia Standard Distractor Shaft 20X80mm Fixed Longitudinal Blade Patella Planer, 31mm Retractor, Right Universal Handle Gorilla, Sinus Tarsi, Support Plate Inserter Pin Stability XXmm Retrc Bld Spreader 32mm Modular Acetabular Insert Impactor Tibial Broach Stem Size 25mm Femur Impactor Head Evans Wedge Trial Size 10/12 Anteversion Rod Straight Full Length Trial Inner Dilator Patella Clamp 18mm Dia Standard Distractor Shaft 23X80mm Fixed Discectomy Blade Straight Osteotome 18x16Rasp Center Handle, Slap Hammer 9x14x11 Drill Guide Trial Fem Neck OST Ruler Tibial Insert Trial, PS-Max; Size 4 Femoral Trial Size 1 Handle for Diamond Saw DTS Guide Round Tube Oval Funnel 16mm Working Channel Distractor Tip, 9mm Drill Guide Handle 12mm Bullet Distractor Mod Trimline Blade L=XX W=35 Counter Torque Slotted Patella Sizer/Drill Guide/Tibial Stem Wrench In-Line Distractor, QC, 10.5mm Wide 10/12mm Distractor Tip 6.35 DISTRACTOR 4/4.5/5.5/6.2 Depth Gauge Jones Screw 12mm Beveled Bone Funnel Provisional Set Screw, Quick Connect 17 x XXmm Discectomy Blade Derotator Slotted Femur/Tibia Implant Impactor Handle Modular Distrator Tip, 30mm, RH Ejector Rod w/Bent Handle Biopsy Center Drill Angled Osteotome Cotton Wedge Trail Size 5/6 Blade, Wide, Toothed, 50L X XXW Distal Femoral cut guide Angled Full Length Trial Tibial Insert Trial, PS-Max; Size 2 Retractor, Leverage Retractor, Right Side Handle Assembly, Egg Shape Femoral Trial Size 4 Graft Delivery Gun Bone Funnel, Square Discectomy Blade Screw Extender Distractor Blade Adaptor, Left 5.5 mm Rod Holder Tibial Insert Trial, PS-Max; Size 1 Plier Plate Bender,Mini 4cm Narrow Blade Blade Narrow 11cm 36mm Modular Acetabular Insert Impactor Femoral Trial Size 5 8x14x11 Drill Guide Trial 22mm Dia Standard Distractor Shaft 10mm/5mm Fixed Distractor Fluoro Marker Blade Adaptor, Right Base Femoral Trial Size 6 All Poly Tibial Impactor Head 3-in-1 Drill Articulating Distractor RH Ball Handled Probe Blade, Wide, Toothless, Curved, 40L X XXW Oval Tube Assy 2.3mm, 0 Degree Graft Stamp Die Plate Precut 10/16mm Distractor Tip Micro Nerve Hook, Small Blunt PS-Post Box Resection Guide Round Funnel Angel Wing Femoral Trial Size 7 7.2 OD Depth Guage Beaming Screw 23X40 Dbl Hole Cerv Endo Blade 12mm Working Channel Retractor Blade, 25-45mm Wide Size 30 Thru 70 Straight Bone Inserter Funnel, Graft Delivery Gun Simple Gap Block Straight 8/10 6/8mm Distractor Tip Center Drill General 14mm x XXmm Longitudinal Blade Distractor Screw Hook Holder Blade Retractor TL XXmm RH Curette Small 20 Degree Low Profile DL Blade, Left Precision Guide, NC-Fusion Right Facet Graft Holder Osteotome Straight w/Handle 14mm Bullet Distractor 2.8mm, 10 Degree Hammertoe Stamp Cutting Die Precut 28mm Modular Acetabular Insert Impactor Flexion Extension Cut Block Femoral Trial Size 2 7x14x11 Drill Guide Trial 25/50mm Reamer 8cm Wide Blade Universal Impactor Head SM 4 Degree, Size=XXmm Perimeter Trial 5 & 5.5 Beaming Depth Gauge Jones Screw Threaded Knob, M3 Tibial Broach Stem Starter 10mm Bullet Distractor Depth Gage, 60mm Tibial Sizer Size 1 Tibial Alignment Guide Upper Tower 6x14x11 Drill Guide Trial Sequential Reducer Outer Assembly Simple Gap Block Straight 16/18 Distractor Tip, Size 15 14mm x XXmm Fixed Longitudinal Blade 18mm Dia Modular Distractor Shaft Modular Spreader 10/14mm Distractor Tip In-Line Distractor, QC, 8.5mm Wide 70mm Post/80mm Blade Retractor Incision Guide, Sinus Tarsi Support Plate, Medium (Peek) In-Line Distractor, QC, 11.5mm Wide Straight Cup Inserter 5.5/6.5 TLIF/PLIF Distractor Tibial Broach Stem Size 100mm Instrument, 2mm Wire, 6 in length Patella Osteotomy Guide Bone Awl TL Blade-Long 14X25 Retractor, Left MIS Lapidus Flute Cleaner 6mm Bullet Distractor Distractor Clamp Assembly Tissue Protector Osteotome Curved w/Handle Malleable Guard - Small Helicopter Removal Tool, 6.35mm Femur Extractor/Impactor Sharp Tip Pedicle Marker Curette Large 20 Degree Tibial Broach Assembly SZ 1-2 Bone Funnel Metrx Tube Retractor 26mm X 10cm Instrument, 2mm K-wire, 9.5in length 10mm Periosteal Elevator Reducer T-Handle Long Blade XXmm X 35mm Helicopter Removal Tool, 5.5mm Tibial Insert Trial, PS-Max; Size 5 Tibial Alignment Guide Lower Tower Multilevel Distractor Blade, Wide, Toothless, Curved, 50L X XXW Cotton Wedge Trial Size 7/8 Simple Gap Block Straight 12/14 Universal Cut Block Probe Lumbar Straddle Plate Precision Guide Speculum XXmm Parallel Compressor, Extra Large Outer Dilator OLIF Round Blade Caudad Tibial Broach Assembly SZ 5-6 Plate Holder 4.75 TLIF/PLIF Distractor Modular Distrator Tip, 35mm, LH Ball Handle Plate Holding Pin_Venture Bone Inserter Tibial Sizer Size 5 Trimline Longitudinal Blade, 80mm Pin Holder 16mm Right Half Tube General SS 6mm Distractor 16mm Dia Standard Distractor Shaft Tibial Sizer Size 6 Extended Slap Hammer Sounding/Feeler Probe, 1mm Extra Long Thoracic Ball Handle Probe Cann Probe - Outer Med Flat Tip Angled Probe Phenolic Ball Handle Probe Lumbar Straight Ball Handle Probe Cann Probe - Inner Rigid Holt Probe Round, Shaft Large Custom Probe Ball Handle Thoracic Probe Short Bayoneted Penfield Push/Pull Assy Cannulated Iliac Probe Long Sounding/Feeler Probe 1mm, Bent Sharp Hook Bayoneted T-Handle Straight Thoracic Probe Ball Handle Straight Thoracic Probe Sharp Iliac Probe Obturator Thoracic Straight Ball Handle Probe Ball Tip Probe Small Custom Probe Long Ball Handle Probe Dual Ended Feeler Probe Extra Long Thoracic Probe 45 Deg Probe LCF K-Wire Guide K-Wire Guide 1.40mm K-Wire Guide 1.60mm Hy Mini Pin Distractor 1.2mm and 1.6mm K-Wires Precision Guide Set Screw 6.4 XL 8 Degree, Size=XXmm Perimeter Trial LG 8 Degree, Size=XXmm Perimeter Trial MD 8 Degree, Size=XXmm Perimeter Trial LG 12 Degree, Size=XXmm Perimeter Trial Pin Holder Screwdriver with Step 4.75mm for Osteogrip Mas Screw 17mm Discectomy Blade 2.4mm Flute Less Drill Bit 3.3mm OD X 20cm Cannulated Drill OverDrill, Solid 2mm X 9cm, SS Retractor, Left Side 12mm Drill Bit Overdrill, Solid2.5mm X 10cm, SS 5.5/6 MAS Lock Sleeve Screwdriver 1.5mm Drill Bit Hammertoe 2.15mm X 70mm Cannulated Drill Drill, Solid 1.6mm X 11cm, SS Drill Bit 3.7mm 3.5 OD X 20cm Cannulated Drill Tibia Coupled ARC Mill Template Drill Solid 1.3mm X 10cm, SS Tibia Coupled ARC Drill Template Threaded Inserter Pin Holder Finish Broach 6mm Broach Pilot Broach Broach AWL, Inline Handle, Short AWL, Inline Handle, Long U Joint Awl Short AWL, Retractable T-Handle Licina AWL Shaft Round AWL Awl, Fixed Handle Straight Broach Holder Solid Trigger Modular Broach Holder MotoBAND CP, Large Bender MotoBAND CP, H10 Driver 16 x XXmm Multi-Tooth Disc Blade Fixed Discectomy Blade, XXmm Fixed Longitudinal Blade, XXmm SS TL Blade w/4 Teeth, 60mm Wide Blade Trimline Micro Blade 14MM X 40/50MM Long Sagittal Sizing Guide Sz 4 Infinity Total Ankle System Sagittal Sizing Guide Sz 1 & 2 Infinity Total Ankle Sagittal Sizing Guide Sz 5 Infinity Total Ankle System Sagittal Sizing Guide Sz 3 Infinity Total Ankle System Compression Spring - SpeedButton Inserter Angled Elevator 17mm Distractor Tip T-Handle Distractor Facet Freer Elevator CD HORIZON Spinal System, IPC POWEREASE System Bone Hook, Pick 3mm Tap, Trocar Tip 3.5mm Tap Shaft, 10-46mm 3.5mm Tap, Trocar Tip 5.5mm Cann Tap Bone Fenestration Chisel Bone Rasp, 7mm 2.75mm Tap Cann Tap, 4.5 Short Crest Dual Start Threads 1/4 Hex Adapter MAS Rod Pusher / Counter Torque T-Handle Counter Torque Dual Handle Closed Counter Torque Wrench 5.5/6 Window Counter Torque Window Counter Torque 6.35 5.5/6 Closed Counter Torque Short Cannulated Rod Pusher/ Countertorque 13.5mm Socket Adapter Femur Extractor/Impactor Head Patella Planer, 37mm Femur Impactor Head Patella Sizer/Drill Guide/ Tibial Stem Wrench 3.5mm Skinny Metal Screwdriver General SS 12.7mm Osteotome General SS 6.35mm Osteotome AO Driver Handle Assembly - Large Cannula AO Driver Handle Ball Plunger Snap Off Driver - Shaft AO Driver Handle Set Screw Motoclip Loading Block Instrument, Motoclip, Template, Split Ring Motoclip Inserter Assembly Crossclip Drill Guide Assembly Drill Guide Saddle Plate Baby Gorilla, 5th MET Hook Screw, Drill Guide Centering Drill Guide Gorilla Sinus Tarsi Drill Locking Guide Gorilla, Mini, Drill Guide, Compression Slot Mini Plate Drill Guide Syndesmosis 3.9mm Drill Guide Ankle Fracture, Drill Guide Hook Plate Gorilla, R3Con, Drill Guide Centering Gorilla mini, Drill Guide, Locking/Threaded Depth Gauge Hook Depth Gauge MotoBAND CP, Depth Gage Assembly Syndemosis Depth Gauge 7.2 OD Depth Gauge Beaming Screw Crossroads Bone Screw Depth Gage 2.3mm Hammertoe Press Shoe 0 Degree Graft Kyphotic Distractor/Compressor 2.8mm Hammertoe Press Shoe 0 Degree Graft Gorilla R3Con, Drill Guide Compression Slot Harris-Yoon, Mini Pin Distractor 2.3mm Hammertoe Press Shoe 10 Degree Graft 2.8mm Hammertoe Press Shoe 10 Degree Graft Parallel Compressor 80mm/35mm Bayoneted Reverse Pull 1.8mm 13F Down Curette Rotate Cutter Rake STR Curette Long Small Reverse 12mm Long Cup Curette 5B Down Curette 8B Down Curette Small Reverse Angle Curette 8F Down Curette Small Reverse Angle Curette, Rotated Mini Curette, Large, 20 Degrees 5F Down Curette Small Reverse Angle Cup Curette Bayoneted Curette 2.7mm FWD Angle R&L Straight Rake Curettes Angled Ring Curette R&L Inferior Uterine Curette 8mm Ring Curette Right Straight Cup Curette Right Angled Cup Curette DTS Guide Assembly Superior Uterine Curette Left Angled Cup Curette Driver Graft Tamp Wide Bone Funnel Tamp Small Tamp Tamp Extended Bone Funnel Tamp Round Tamp Ankle Fracture, Tamp Dual Hook Baby Gorilla, 5th MET Hook Plate Dual Offset Tamp Baby Gorilla, 5th MET , Plate Hook Single Tamp Bayoneted Probe/Tamp Oval Tamp Graft Tamp and Handle Ankle Fracture, Tamp Single Hook Bone Graft Tamp Evans Wedge 9 deg, Xmm Assembly Cotton Wedge Xmm Assembly Bone Fenestration Chisel Bone Fenestration Chisel, Curved Refresh Chisel Straight Box Chisel 4mm x 18mm Depth Gage-Long AO Driver Handle Assembly - Large Cannula K-Wire .9 x 150mm Bone Screw Depth Gage Gorilla, Mini, Drill Guide, Compression Slot Gorilla, Silverback, Drill Guide Compression Slot Gorilla, R3con, Drill Guide Compression Slot Bone Rasp Lead Forceps Straight Bayoneted Forceps Plate Holder Forceps Implant Inserter 18mm Screw Remover 6.35mm Bone Screw Extractor Harvester Door Assembly Bone Graft Harvester Body Assembly Bone Screw Trephine Rasp 15 Deg 5.5/6mm Rod Reducer Shaft, Oval Rasp 14x10 Rasp 18x16 Rasp Rasp, 12mm Flat Two Sided Bayonetted Rasp 20x18 Rasp X.Xmm Rasp 16x13 Rasp Rasp Handle 10mm-14mm 12 Deg Rasps 22mm C-Tube Retractors 30-50mm Length 14mm Blunt Blade Wide Longitudinal Self-Ret, Retractor Assy 8cm Narrow Blade Midlif Blade 4-10cm L&R 20mm Washer 6cm Narrow Blade 45 x XXmm Longitudinal Blade METR x Dilator 30.8mm Malleable Retractor, 6mm Retractor Blade LL Left 10 inch Retractor 8.5mm Narrow Blade L=30-70mm 20mm x 80mm Fixed Longitudinal Blade 9cm Retractor Blade Retractor Rack Assembly Wide Blade Large Arc 40mm Nerve Root Retractor 12.7mm 6 inch Retractor 12cm Wide Blade Malleable Retractor, 12mm Retractor Hook Dilator 7.8mm 25mm X 11cm Expanding Retractor Hand Held Retractor, 13cm Hand Held Retractor, 7cm MX Tube Retractor 22mm 20mm Tubular Retractor, flat Suction Retractor, Extra Wide 14mm x XXmm Blunt Blade Wide Blade Large Arc 50mm 30-70mm Long Teeth Discectomy Blade Hand Held Retractor/Screw Lever 40-90mm Blade Right and Left Hand Held Retractor, 18cm 22mm Angled Tubular Retractor Nerve Root Retractor 6.35mm Small Retractor, Right Side Retractor Blade, 18mm 20mm Tubular Retractor, Beveled 11cm Retractor Blade 20mm Hand-Held Retractor 24mm Tubular Retractor, flat 10cm Wide Blade OLIF Round Blade w/Radial Cut, Caudad MX Tube Retractor 26mm Torque Limiting Screwdriver Dual Bracket Tubular Retractor, 19mm x 9cm Malleable Retractor, 8mm Longitudinal Blade w/ Extension Retractor Blade LL Right 11cm Wide Blade 24mm Tubular Retractor, Beveled Malleable Retractor, 10mm 4mm Distractor Custom Midline Blade, Right 22mm Washer Custom Midline Blade, Left 9mm X 100 Deg Nerve Root Retractor Dural Retractor 100-110mm Longitudinal Blade Right & Left Retractor Blade, 28mm Retractor Right Retractor Double Hole Blade XXmm 30-70mm Short Teeth Discectomy Blade Weitlaner Retractor w/Splines Small Retractor, Left Side METR x Dilator 26.8mm Nerve Root Retractor 9.5mm OLIF Round Blade w/Radial Cut, Cephalad Flex Arm Attachment 18mm x XXmm Expanding Retractor Left Retractor Medium Retractor 10cm Narrow Blade Impactor Housing Impactor Staple Impactor with AWL Wire pushers Clamps 6mm x 45mm L Distractor / Trial 4mm x 45mm L Distractor / Trial 50mm Rod Template Midline Plating Template 20-35 mm Spacers AO Driver Handle Assembly - Large Cannula Bone Screw Depth Gage Snap Off Driver - Shaft Depth Gage-Long K-Wire 1.1 x 150mm K-Wire 0.9 x 150mm Post Guided Face - Cutting Reamer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-12-30
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-12-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-02-15
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2018-01-29
HXB Probe Orthopedic Class 1 888.4540 2015-11-13
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-03-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-11-13
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2018-01-29
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-01-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-11-16
HTQ Broach Orthopedic Class 1 888.4540 2015-11-13
HWJ Awl Orthopedic Class 1 888.4540 2018-01-29
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2015-12-17
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2015-12-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2015-12-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-02
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2015-11-13
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2018-01-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-12-26
HTE Elevator General, Plastic Surgery Class 1 878.4800 2015-11-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-05-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-05-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-05-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-05-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-05-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-05-21
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-05-21
HWX Tap, Bone Orthopedic Class 1 888.4540 2018-01-29
HXC Wrench Orthopedic Class 1 888.4540 2018-01-29
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-12-17
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2018-12-26
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2019-12-30
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-02
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-03-23
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2015-11-13
HWN Instrument, Compression Orthopedic Class 1 888.4540 2018-01-29
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-01-29
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-12-27
HXG Tamp Orthopedic Class 1 888.4540 2015-12-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-23
PLF Bone Wedge Orthopedic Class 2 888.3030 2018-03-23
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-01-29
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-02
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-12-30
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-12-30
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2013-02-15
HTD Forceps General, Plastic Surgery Class 1 878.4800 2015-11-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-12-17
HWB Extractor Orthopedic Class 1 888.4540 2018-01-29
HWK Trephine Orthopedic Class 1 888.4540 2018-01-29
HTR Rasp General, Plastic Surgery Class 1 878.4800 2015-11-13
GAD Retractor General, Plastic Surgery Class 1 878.4800 2015-11-13
HWA Impactor Orthopedic Class 1 888.4540 2018-01-29
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2013-02-15
HWT Template Orthopedic Class 1 888.4800 2020-12-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-02
HTO Reamer Orthopedic Class 1 888.4540 2015-11-13

Official Correspondent

Jason Hatchel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedTech-LLC
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
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22
K030577 Stelkast Company PROVEN MODULAR TIBIAL TRAY 2003-03-25
K153310 Total Joint Orthopedics, Inc. Klassic Knee System 2015-12-17
K102380 Wrightmedicaltechnologyinc EVOLUTION MP TOTAL KNEE SYSTEM 2011-01-07
K122985 Aesculap Implant System, Inc. COLUMBUS REVISION KNEE SYSTEM 2012-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019 Smith & Nephew, Inc. 2
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06 Plus Orthopedics USA 2
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010123256. Last updated year: 2026. Please use registration number 3010123256 when referencing this establishment in official correspondence.
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