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
- [email protected]
- Phone
- 208 8616488
Products
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