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
- [email protected]
- Phone
- 208 8616488
Products
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