FDA Registration Active 🇮🇳 India

Tapered Half Pin 170 X 40 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating

Reg #: 3013747584 · FEI: 3013747584 · Expires 2025
Products
2
Proprietary Names
68
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
K200518

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

Tapered Half Pin 170 X 40 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating Rail Pediatric- 150 mm, 200 mm, 25 mm, 300 mm ALFA Rail- 150 mm, 200 mm, 250 mm, 300 mm, 350 mm, 400 mm Tapered Half Pin 100 X 20 X 6 mm Tapered 3.5 mm To 4.5 mm with Hydro apatite coating Tapered Half Pin 130 X 50 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA A-P Angle Attachment Clamp ALFA Pediatric Rail- 150 mm, 200 mm, 250 mm, 300 mm Graduated Swivel Clamp Tapered Half Pin 130 X 30 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Rail Bolt- M6 X 27 mm and M6 X 30 mm Multi-Axial Clamp ALFA Standard Clamp Hinge Connection CD unit Pediatric Tapered Half Pin 120 X 40 X 6 mm Tapered 3.5 mm To 4.5 mm with Hydro apatite coating Advanced CD Unit- 40 mm, 80 mm, 100 mm Sandwich Plate Tapered Half Pin 200 X 50 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating Tapered Half Pin 110 X 30 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Pediatric Standard 1 Hole Clamp ALFA Rail Bolt M6 X 5 mm T Ball & Socket Clamp Pediatric ALFA Pediatric Stacked 3 Hole Overhang Clamp ALFA Stacked 5 Hole Overhang Clamp Bolt For Sandwich Plate ALFA Pediatric Rail Hinge – Female, Male ALFA Locking Nut M6 X 6 mm Tapered Half Pin 200 X 40 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating Ball And Socket Clamps Tapered Half Pin 120 X 30 X 6 mm Tapered 3.5 mm To 4.5 mm with Hydro apatite coating ALFA Pediatric Standard 3 Hole Clamp Swivel clamp Pediatric T Clamp Pediatric ALFA Rail Arc Rotation End Central Clamps ALFA Pediatric Rail End Cap – Female, Male Tapered Half Pin 100 X 30 X 6 mm Tapered 3.5 mm To 4.5 mm with Hydro apatite coating ALFA Rail Bolt Cannulated- M6 X 28 mm and M6 X 38 mm Metafacial Clamp for Rail System Tapered Half Pin 200 X 60 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Pediatric A-P Angle Attachment Clamp ALFA Pediatric Standard Clamp - Hinge Connection Tapered Half Pin 150 X 30 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Rail Arc Clamp Tapered Half Pin 170 X 60 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating T Ball And Socket Clamp for Rail Fixation System Tapered Half Pin 130 X 40 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating Dyna Ring Swivel Clamps ALFA Rotation End Connector ALFA Compression and Distraction Device ALFA Rail Hinge – Male, Female ALFA Pediatric Rotation End Connector ALFA Rail End Cap- Male, Female End Clamp ALFA Standard 3 Hole Clamp Tapered Half Pin 150 X 50 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating Tapered Half Pin 170 X 50 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Pediatric Rail Arc Clamp ALFA Arch Small 90 Deg, Medium 120 Deg, Large 180 Deg ALFA Rail Bolt M6 X 7 mm ALFA Standard 1 Hole Clamp ALFA Pediatric Rail Arc Rotation End T Clamp ALFA Pediatric Arc- Small 90 Deg, 120 Deg, 180 Deg ALFA Stacked 3 Hole & 5 Hole Clamp Rail- 200 mm, 300 mm, 400 mm, 600 mm Tapered Half Pin 150 X 40 X 6 mm Tapered 5 mm To 6 mm with Hydro apatite coating ALFA Rail Set Screw M6 X 7.5 mm

Establishment Types

Manufacture Medical Device