FDA Registration
Active
🇺🇸 United States
Biopsy Center Drill
Reg #: 3010123256
·
FEI: 3010123256
·
Expires 2025
Products
1
Proprietary Names
297
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTECH LLC
- Registration Number
- 3010123256
- FEI Number
- 3010123256
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8022 Martha Rd
- City
- Millington
- State
- TN
- ZIP
- 38053
- Country
- US
Owner / Operator
- Firm Name
- MedTech-LLC
- Operator Number
- 10043432
- Address
- 8022 Martha road
- City
- Millington
- State
- TN
- Postal Code
- 38053
- Country
- US
- Correspondent
- Samantha Reed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-15 |
Proprietary Names
Biopsy Center Drill
Sequential Reducer Outer Assembly
General Tissue Protector, Jones Screw
Blade, Wide, Toothed, 50L X XXW
Curved Anterior Spreader Narrow
90 Deg Compressor-Small
Instrument, 2mm Wire, 4 in length
Patella Sizer/Drill Guide/Tibial Stem Wrench
In-Line Distractor, QC, 10.5mm Wide
Modular Distrator Tip, 30mm, LH
Tibial Sizer Size 4
14X40 Long Tooth Disc Blade
28mm Modular Acetabular Insert Impactor
4.75 TLIF/PLIF Distractor
Instrument, 2mm K-wire, 9.5in length
10mm Periosteal Elevator
Long Blade XXmm X 35mm
Straight Shaft Cup Inserter
Intramedullary Rod
Distractor Pin Driver
8mm Bullet Distractor
Screw Extender Distractor
Round Funnel
7.2 OD Depth Guage Beaming Screw
TL Blade-Long 14X25
Retractor, Left
MIS Lapidus Flute Cleaner
General 14mm x XXmm Longitudinal Blade
Distractor Screw
ACDF Pin Distractor
23X80mm Fixed Discectomy Blade
18x16Rasp
Spreader Vertebral Body
Patella Osteotomy Guide
Derotator Slotted
Femur/Tibia Implant Impactor Handle
25/50mm Tibial Stem Ream Guide
Blade Retractor TL XXmm RH
Curette Small 20 Degree
Distal Femoral cut guide
6.35 DISTRACTOR
Shaver 6mm Disc
Distractor Tip, Size 15
Straddle Plate Precision Guide
Hand Tamp
Parallel Compressor, Extra Large
Malleable Guard - Medium
Tibial Sizer Size 1
Tibial Sizer Size 2
Angled Osteotome
Cotton Wedge Trail Size 5/6
Metrx Tube Retractor 26mm X 10cm
Inner Dilator
10/12mm Distractor Tip
Precision Guide, NC-Fusion Right
Femur Impactor Head
Curette Large 20 Degree
Mod Trimline Blade L=XX W=35
Distractor Tip, 13mm
Low Profile DL Blade, Left
Can Opener
Head Adjuster with Silicone Handle
Femoral Trial Size 2
In-Line Distractor, QC, 7.5mm Wide
70mm Post/80mm Blade Retractor
12mm Beveled Bone Funnel
Straight Cup Inserter
Tibial Broach Stem Size 100mm
Oval Funnel
T27 Screwdriver with T-Handle
Osteotome Curved w/Handle
Tibial Insert Trial, PS-Max; Size 4
14mm Bullet Distractor
Discectomy Blade
Plate Holding Pin_Venture
Reducer T-Handle
Tibial Sizer Size 5
General SS Adjustable Cobb
Tibial Insert Trial, PS-Max; Size 6
Blade Retractor TL XXmm LH
2.8mm, 10 Degree Hammertoe Stamp Cutting Die Precut
10/16mm Distractor Tip
Instrument, 2mm Wire, 6 in length
Ball Handle
6/8mm Distractor Tip
Femoral Trial Size 3
Driver Shaft
14mm Fixed Discectomy Blade, XXmm Long
Distractor Frame Clamp
14mm Working Channel
Bone Funnel, Tamp
PS-Post Box Resection Guide
23X40 Dbl Hole Cerv Endo Blade
Trimline Longitudinal Blade, 80mm
Center Drill
25/50mm Reamer
TL Blade-Disc
Lapidus Nail Locking Guide
22mm Dia Standard Distractor Shaft
General 20mm x XXmm Longitudinal Blade
Spreader
32mm Modular Acetabular Insert Impactor
Blade Adaptor, Right
Handle Assembly, Egg Shape
5x14x11 Drill Guide Trial
14mm Dia Modular Distractor Shaft
10/20mm Distractor Tip
In-Line Distractor, QC, 8.5mm Wide
Precision Guide, NC-Fusion Left
Distractor Tip, 9mm
TSRH-RP Offset Screwdriver
Outer Dilator
Modular Broach Holder Straight
6mm Bullet Distractor
3-in-1 Drill
Articulating Distractor LH
Distractor Clamp Assembly
6mm x 22mm Cobb Distractor
Dilator Inner Shaft
All Poly Tibial Impactor Head
Modular Distrator Tip, 35mm, RH
12mm Bullet Distractor
16mm Left Half Tube
6.35 Provisional Driver, Short
Evans Wedge Trial Size 10/12
Anteversion Rod
2.8mm, 0 Degree Graft Stamp Die Plate Precut
Blade Narrow 11cm
36mm Modular Acetabular Insert Impactor
Femoral Trial Size 5
Modular Spreader
Angled Full Length Trial
10/14mm Distractor Tip
Tibial Insert Trial, PS-Max; Size 2
Femoral Stem Hoop Extractor
10mm/5mm Fixed Distractor
Fluoro Marker
Straight Osteotome
16mm Working Channel
Drill Guide Handle
Blade, Wide, Toothless, Curved, 50L X XXW
OLIF Round Blade Caudad
Tibial Broach Assembly SZ 5-6
Tibial Broach Assembly SZ 1-2
Syndesmosis Depth Gage
4.5 x 40mm Awl
Tibial Sizer Size 6
5.5 mm Rod Holder
Tibial Insert Trial, PS-Max; Size 1
2.3mm, 0 Degree Graft Stamp Die Plate Precut
16x13 Rasp
Micro Nerve Hook, Small Blunt
Provisional Set Screw, Quick Connect
Simple Gap Block Straight 8/10
17 x XXmm Discectomy Blade
Bone Awl
Malleable Guard - Small
Blade, Wide, Toothless, Curved, 40L X XXW
Helicopter Removal Tool, 6.35mm
Oval Tube Assy
Femur Extractor/Impactor
20X80mm Fixed Longitudinal Blade
Retractor, Right
Plier Plate Bender,Mini
4cm Narrow Blade
14mm x XXmm Fixed Longitudinal Blade
18mm Dia Modular Distractor Shaft
18mm Dia Standard Distractor Shaft
TL Blade-Long
Tibial Insert Trial, PS-Max; Size 3
Angled Blade Adaptor, Left
MIS Tibial Cut Block - Left- Frog Eyes
Straight Full Length Trial
8/10mm Distractor Tip
Tibial Sizer Size 3
Gorilla, R3con, Drill Guide, Centering
Plate Cutter, Double Action 230mm, Straight
8/8mm Distractor Tip
Simple Gap Block Straight 16/18
Simple Gap Block Straight 12/14
Universal Inserter, Assembly
Universal Cut Block
OLIF Round Blade Caudad, Cephalad
Tibial Broach Stem Size 25mm
10mm Inserter
Cotton Wedge Trial Size 7/8
ARC Mill Bushing-Body
AP sizer
Threaded Knob, M3
Tibial Broach Stem Starter
Femoral Trial Size 6
5mm Distractor
8cm Wide Blade
Universal Impactor Head
SM 4 Degree, Size=XXmm Perimeter Trial
5 & 5.5 Beaming Depth Gauge Jones Screw
Pin Stability XXmm Retrc Bld
Alignment Tool
5.5/6 Distactor Pin
Femoral Trial Size 4
Graft Delivery Gun
Extra Wide Discectomy Blade XXmm X 40mm
Biopsy Drill Retractor
Sharp Tip Pedicle Marker
Bone Funnel
Plate Holder
Counter Torque Slotted
Lapidus Nail, Tissue Protector Assembly
13mm Disc Shaver
Flexion Extension Cut Block
Blade Adaptor, Left
7x14x11 Drill Guide Trial
Multilevel Distractor
Slap Hammer
3.5mm Skinny Metal Screwdriver
Calcar Planer
Angled Blade Adaptor, Right
10mm Bullet Distractor
Dilator 24.8mm
16mm Discectomy Blade
Depth Gage, 60mm
Bone Funnel, Square
12mm Working Channel
Incision Guide, Sinus Tarsi Support Plate, Medium (Peek)
Handle for Diamond Saw
Low Profile DL Blade, Right
10/18mm Distractor Tip
Compressor Distractor 5.5 Long
Hook Holder
Longitudinal Blade
Laminar Spreader
Threaded Probe
5.5 Rod Pusher
Retractor Blade, 25-45mm Wide Size 30 Thru 70
Straight Bone Inserter
Funnel, Graft Delivery Gun
Blade, Wide, Toothless, Curved, 30L X XXW
Modular Distrator Tip, 35mm, LH
Ratch, Ultra Mini Axial Pull A-O, Spin Cap
Tibial Insert Trial, PS-Max; Size 5
Bone Inserter
Tibial Broach Assembly SZ 3-4
Distal Femoral Cut Guide, Fixed ,5 Deg
Helicopter Removal Tool, 5.5mm
5.5/6 TLIF/PLIF Distractor with Extended Rack
Pin Holder
16mm Right Half Tube
Tibial Alignment Guide Lower Tower
20mm Dia Standard Distractor Shaft
General SS 6mm Distractor
16mm Dia Standard Distractor Shaft
Round Tube
2.3mm, 10 Degree Hammertoe Stamp Cutting Die Precut
5.5/6 Distractor Pin
In-Line Distractor, QC, 9.5mm Wide
Depth Gage, 50mm
5.5 Depth Gage Lateral Column Fusion
Patella Planer, 37mm
Patella Clamp
Facet Graft Holder
8x14x11 Drill Guide Trial
Osteotome Straight w/Handle
6.35 Provisional Driver
Base
9x14x11 Drill Guide Trial
Patella Planer, 31mm
Modular Distrator Tip, 30mm, RH
Retractor, Leverage
Universal Handle
Gorilla, Sinus Tarsi, Support Plate Inserter
MIS Tibial Cut Block - Right - Frog Eyes
Speculum XXmm
Evans Wedge Trial Size 6/8
Alignment Rod
4/4.5/5.5/6.2 Depth Gauge Jones Screw
In-Line Distractor, QC, 11.5mm Wide
5.5/6.5 TLIF/PLIF Distractor
Ball Handled Probe
Femoral Trial Size 1
DTS Guide
Retractor, Right Side
Probe Lumbar
Distractor w/90 Degree Handles
Distractor Tip, 11mm
8mm Straight Distractor 8 Deg
Tibial Alignment Guide Upper Tower
Femoral Cutting Block
6x14x11 Drill Guide Trial
Instrument, STROPP, 2.8mm Pin
Tissue Protector
Articulating Distractor RH
Center Handle, Slap Hammer
Fem Neck OST Ruler
Angel Wing
Femoral Trial Size 7
Gorilla, Mini Plate Bender, Threaded Bending Bar
Ejector Rod w/Bent Handle
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)