FDA Registration Active 🇮🇳 India

Aluminium Half Rings Internal Dia 140 mm, 160 mm, 180 mm, 200 mm, 220 mm

Reg #: 3013747584 · FEI: 3013747584 · Expires 2025
Products
2
Proprietary Names
73
Establishment Types
1
Classifications
2

Registration Details

Registration Name
S.H.PITKAR ORTHOTOOLS PVT. LTD.
Registration Number
3013747584
FEI Number
3013747584
Status
Active
Expiry Year
2025
Initial Importer
No
Address
EL 32, J Block, MIDC Bhosari, Pune
City
Pune Maharashtra
Country
IN

Regulatory Submissions

510(k) Number
K190486

Owner / Operator

Firm Name
S.H.Pitkar Orthotools Pvt. Ltd.
Operator Number
10087372
Address
EL 32, J Block,, MIDC Bhosari
City
Pune
State
Maharashtra
Postal Code
411026
Country
IN
Correspondent
Vivek Mangalwedhekar

US Agent

Business Name
Premkumar Reddy Medical, USA LLC
Contact Name
Premkumar Babu
Address
808 Independence Dr
City
Harleysville
State
PA
ZIP
19438
Country
US
Phone
208 8616488

Products

Device Name Product Code
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Pin, Fixation, Threaded JDW

Proprietary Names

Aluminium Half Rings Internal Dia 140 mm, 160 mm, 180 mm, 200 mm, 220 mm Square Nut Telescopic Rods- Length 100 mm to 400 mm Curved Plates Holes 3 Wire Fixation Bolts Cannulated and Cannulated with Threaded Head Composite Foot Ring- Internal Dia 120 mm to 180 mm Aluminium Conventional Ring Short Arm and Long Arm- Internal Dia 120 mm, 140 mm, 160 mm, 180 mm Hinges-Female Standard, Low Profile Thin Nut Tapered Half Pin 130 X 40 X 6 mm Tapered 5 mm To 6 mm Nylon Insert Nut Italian Femoral Arches 90 Degree Arch- Small Size, Large Size Tapered Half Pin 150 X 50 X 6 mm Tapered 5 mm To 6 mm Oblique Support connection Composite Half Rings with Carbon Reinforcement- Internal Dia 80 mm to 200 mm Star Washer Tapered Half Pin 200 X 50 X 6 mm Tapered 5 mm To 6 mm Bushing Tapered Half Pin 120 X 40 X 6 mm Tapered 3.5 mm To 4.5 mm Hinges-90 degree Standard, Low Profile Aluminium Foot Ring Internal Dia 120 mm, 140 mm, 160 mm, 180 mm, 200 mm, 220 mm Rotational And Translational Device Sleeve For Block for Half Pin 4 mm, 5 mm, 6 mm Aluminium 2/3 Ring Internal Dia 120 mm, 140 mm 160 mm, 180 mm, 200 mm, 220 mm Slotted Washers- Thickness 4 mm Trocar Point-Cancellous Dia 1.5 mm, 1.8mm Length 300mm, 370mm Hinges- Male Standard, Low Profile Wire With Stopper (Bayonet Point) Dia 1.5 mm, 1.8mm Length 300mm, 400mm Tapered Half Pin 100 X 20 X 6 mm Tapered 3.5 mm To 4.5 mm Spacing Washers- Thickness 1.5 mm, 2 mm Universal Joint Tapered Half Pin 200 X 60 X 6 mm Tapered 5 mm To 6 mm Block For Half Pin with Sleeve Holes 1 to 5 Flat Sided Washers- Thickness 2 mm, 4 mm Single Pin Fixation Bolt Tapered Half Pin 120 X 30 X 6 mm Tapered 3.5 mm To 4.5 mm Blocks For Half Pins Holes 1 to 5 Tapered Half Pin 130 X 50 X 6 mm Tapered 5 mm To 6 mm Tapered Half Pin 170 X 60 X 6 mm Tapered 5 mm To 6 mm Post-Male 2 holes to 4 holes Multiple Pin Fixation Clamp Composite Foot Rings with Carbon Reinforcement Short Arm- Internal Dia 80 mm to 180 mm Tapered Half Pin 200 X 40 X 6 mm Tapered 5 mm To 6 mm Short Connection Plates- Length 35 mm, 45 mm, 55 mm, 65 mm, 75 mm, 85 mm, 95 mm, 105 mm, Holes 2 to 10 Tapered Half Pin 170 X 50 X 6 mm Tapered 5 mm To 6 mm Tapered Half Pin 150 X 40 X 6 mm Tapered 5 mm To 6 mm Wire Fixation Bolt Slotted Tapered Half Pin 170 X 40 X 6 mm Tapered 5 mm To 6 mm Tapered Half Pin 130 X 30 X 6 mm Tapered 5 mm To 6 mm Bayonet Point-Cortical Dia 1.5 mm, 1.8mm Length 300mm, 370mm Tapered Half Pin 110 X 30 X 6 mm Tapered 5 mm To 6 mm Graduated Telescopic Rods- Length 60 mm, 80 mm, 10 mm, 150 mm, 200 mm, 250 mm Post- Female 2 holes to 4 holes Hex Nut 6 mm Arches With Holes Internal Radius 90, 110, 120, 140 Threaded Rods-Partial Length 60 mm, 130 mm, 170 mm, 210 mm Twisted Plates- Length 65 mm, 85 mm, Holes 3 & 4 Threaded Sockets- Length 20 mm to 60 mm Tapered Half Pin 150 X 30 X 6 mm Tapered 5 mm To 6 mm Connected Plates with Threaded Ends- Length 135 mm, 175 mm, 215 mm, 255 mm, Holes 5, 7, 9, 11 Long Connection Plates- Length 155 mm, 235 mm, 335 mm, Holes 8, 12, 17 5/8 Ring- Internal Dia 100 mm to 240 mm Half Rings- Internal Dia 80 mm to 240 mm Rings With Curved Extremities 120 mm to 160 mm 13mm Nut Threaded Rods- Length 40 mm to 350 mm Conical Washer Couple Tapered Half Pin 100 X 30 X 6 mm Tapered 3.5 mm To 4.5 mm Connection Bolts- Dia 10 mm, 16 mm, 20 mm, 30 mm Wire Fixation Buckle Split Locking Washers- Thickness 2 mm Threaded Rods-Slotted Length 40 mm to 210 mm Italian Femoral Arches 120 Degree Arch- Small Size, Large Size

Establishment Types

Manufacture Medical Device