FDA Registration
Active
🇮🇳 India
Gouge f/Cancellous Bone-Graft curve w/10 L
Reg #: 3013747584
·
FEI: 3013747584
·
Expires 2025
Products
1
Proprietary Names
328
Establishment Types
1
Classifications
1
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
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
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-08-27 |
Proprietary Names
Gouge f/Cancellous Bone-Graft curve w/10 L
Olecrona Rounger 9
Reduct-Forceps-large w/Points ratchet-lock
Pelvic Instrument set
Pen Type Drill
Dura & Vessel Repairs Kit
Osteotome & Chisel Gouges S.S. 15
Howman's Retractor Small 8
Plate Bone Holding Medium 8
Canulated K Nail Reamer 9 mm
Self retaining Retractor 10
Canulated K Nail Reamer 10 mm
Reduction Forcep - Big
Retractor Short Narrow Tip Small Width 18 mm
Bone Hook, large, long, length 330 mm
Small Fragment Set
Reduct-Forceps-large w/Points speed-lock
Reduc-Forceps toothed ratchet-lock L140
Periost-Elev curv-shaft round edge w/14
Depth Gauge
Reduction Forcep With Point - Mini
Self retaining Retractor 8
Instrument Set For Cervical
Plaster Shaw Heavy Duty
Periosteal Elevator (Farabeaves) f/h 10''
ROUNGER RIGHT ANGLE
Big Bone Cutter 11
Drill Sleeve 3.2 mm
Reciprocating Saw Blade Big 35 mm
Disc punch downward
Reduction Foreceps Size 200 mm
Universal external fixation 8mm set
Periosleal Elevator S.S. 15''
Instrument Set For Locking Plate 5 mm
Instrument set for Calcar Reamer
Chisel-Handle
Iinstrument Set For Eight plate
Plaster Spreader SS 12
Instrument set for Estella Hip System
Health Mallet 500 gms
Universal Locking Nail Instrument Set
Retractor Long Wide Tip (For Hip Surgery) Width 8 mm
Container for Peditric Rail fixation system
Bone holding forcep Self centering length 258mm
Jacob Chuck With T Handle
Instrument Set For mini rail system
Instrument & Implant Set For Stand Alone Cage
Bone Holding Forceps self-center speed-l small
Endoprosthesis Set
Hawman Retractor Medium
Basic Instrument Set
Sol T Proximal Femoral Device Set
Ultra lock Femur Instrument set
Tap 4.5mm L 125 x TL 70mm
Cobs Retractor Set 8''
Bone Lever Serted Plane
K Nail Reamer 12 mm
Osteotome & Chisel Gouges S.S. 5
Surgical Drill Hand Piece
Hammer With Fiber Handle Medium
Lowman Clamp Medium 7
Periarticular Reduction forcep w/ball tips large
Retractor Short Narrow Tip Small Width 8 mm
Small Anatomical System Instrument Set
Periost-Elev slightly curve-blade round e
Osteotome & Chisel Gouges S.S. 10
Bone Holding Forceps f/Tib-Edge Fragment L210
Reduction Medium 8
Canulated K Nail Reamer 8 mm
Self Centring Forcep - Medium
Reduction Forcep - Extra Small
ProMis Tower Instrument Set
Forcep Set
Instrument Set for Elastic Nail
Instrument set for Bipolar Hip System
Disc punch upward
Instrument Set For ALFA Fixator System
Reduction Foreceps Size 280 mm
Universal external fixation 4mm set
Bone Taps With Fixed T Handle 2.7mm (Pitch 1mm)
Compression Device Muller Type
Recon Plate Bender 4.5
T Handle Chuck Key
Cannulated Cancellous set 4mm
Hexagonal Screw Driver 3.5 mm Width Across Flat
Bone Holding Self Cenetring forcep Medium
Kerrison Punch Detachable Instument Set
Instrument set for Droner peek cage
Micro Lumbar Discectomy Set
Surgical Saw Hand Piece
Pneumatic Tourniquet
Instruments Set For MIS Tube Retractor
Mastroid Retractor 250 mm
Gilpe Retector 4
Patella forcep w/ serrated jaw large
McCULLOCH retractor frame for microdiscectomy
Drill Sleeve 4.5 mm
Ball Spike, straight, long, with pointed ball tips dia 6.5 mm, length 400 mm
Instrument Set For Trocantric Femoral Nail
Reduction Forcep With Point - Small
Posterior Cervical Instrument Set
Haygroove Forcep 10"
K Nail Reamer 8 mm
Instrument Set For Calcaneal fixator system
Bone Curettes Small
Wire Passer
Plate Bandar Pair 8
Bone Hook sharp small L230
Burns Bone Holding 6
K Nail Reamer 10 mm
Awl Cannulated
Disc punch straight
Wire Cutter 8
Reduction Foreceps Size 140 mm
Rib raspitory left
Anterior Cervical plate Instrument Set
Reduction Forcep - Medium
Lawman Bone Clamp Small
Bone Hook 10
Reciprocating Saw Blade Small 25 mm
Reciprocating Saw
Instrument & Implant Set For Cage With Plate
Lipped-Unlipped Retractor Set
Cannulated Reamer (7,8,9 10)- 1 set
Reduc-Forceps w/Points ratchet-lock L180
Instrument set for Mesh
Humeral Head Retractor
Sergent rounger straight 10
Patella forcep w/ serrated jawMedium
Distal Radius set
Advanced Acetabular Reamer Set
Large external fixator set (11 mm)
Tap Sleeve 4.5 mm
Patela Bone Holding D/P 10
Periosteal Elevator (Farabeaves) f/h 5
Bone Curettes Large
Instrument Set For Locking Plate 2.4 mm
Instrument set for Orion Stem Muller Type Straight
Canulated K Nail Reamer 11 mm
Reduc-Forceps w/Points ratchet-lock L160
Sol T Femur Instrument Set
Acetabular Reamer Set
Instrument set for ACL-PCL System
Titanium T3 Lox Peri-prosthetic cable plate instrument set.
Bone holding stand
YT Instrument Set
Periosteal Elevator (Farabeaves) f/h 15''
Bone Cutter D/a 6
Howman's Retractor Large 30
Bone Taps With Fixed T Handle 3.5mm (Pitch 1.75mm)
Plaster Spreader Alu Hang 12
Bone Nibbler D/a 6
Basic Instrument Set for Ring Fixator Sytem
Howman's Retractor Large 35
Reduction Forcep - Small
Bone Drill Universal Type
Ultra lock Tibia Instrument set
Bone Holding Self Cenetring forcep large
Plate Bander Roller Type
Patela Big Size 12
Cobra Retractor
Bone Hook sharp medium L230
MIS Instrument Set
Self Centring Forcep - Big
Plaster Cutting Scissors
Bone Holding Forceps self-center speed-l large
Bone Tap With Fixd T Handle 4.5 mm [Pitch 1.75 mm]
Vice Grip Length 180 mm Maximun Opening 34 mm Dia
Lowman Clamp Small 6
Asterix Hip Instrument Set
Wire Cutter / Plier 6"
Howman's Retractor Small 15
Reduction Forcep With Point - Big
Hammer 500g
Screw Driver Hex 2.5mm Across Flat
Howman's Retractor Extra Large 60
Lamina Spreader 12
Retractor Short Narrow Tip Width 18 mm
Sergent rounger curved 10
Condylar Blade Plate Instrument Set
Spinal Deformity Instrument Set
Instrument Set for Hybrid Jacx Cage
Reduc-Forceps w/Points ratchet-lock L130
Periosteal Elevator Farabeuf Type Curved
Dura Retractor
Plate Bone Holding Small 6
Minimully Invasive Retractor System
Howman's Retractor Extra Large 45
Small external fixator set ( 4mm)
Patella Holding Foreceps 200 mm
K Wire Bender Z Shaped
Bone Gauges
Gilpi Retractor Medium
Kerrison Punch 1 mm
Cervical Lock Plate Instruments Set
Bone nibbler double action straight 7
Instrument set for Atlax System
Bone Hook, medium, long, length 330 mm
Tuder edward bone cutter
Instrument Set For Plif & Tlif Cages
Kochar's Bone Hook Medium
Chisel With Detachable Handle Straight 10 mm To 25 mm
Instrument set for Vulcan Hip System
Cannulated Cancellous set 7mm
Osteotomes Straight 15 mm
K Nail Reamer 11 mm
Periarticular Reduction forcep w/ball tips medium
Reduc-Forceps toothed speed-lock L140
Ultra lock Femur Instrument set with Distal
Reduction Large 10
Gouge With Fiber Handle 10 mm
Bone Cutter D/a 7.5
Reduction Forcep With Point - Medium
Haygroove Forcep 12"
Instrument Set For Locking Plate 3.5 mm
Patella forcep w/ serrated jaw(Small)
Hammer With Fiber Handle Big
Retractor Large
Periosleal Elevator S.S. 5
Mcdonalds Retractor
Universal Femur Instrument set with Distal
Sol T Tibia Instrument Set
Rib raspitory right
LACKSELL ROUNGER
Bionet correction punch 8
Instrument Set For Pediatric DHS Plate
Mastroid Retector 4
Bone Nibbler S/a 6
Instruments Set For Trigen
Bone holding forcep Self centering length 250mm
Screw removal instrument set
Reduction Foreceps Size 240 mm
Instruments set for Hemiarthroplasts.
Mastroid Retractor 200 mm
Howman's Retractor Extra Large 50
Lowman Clamp Large 8
Instrument set for Saturn Bipolar Cup System
Block for Half Pin
Reduction Foreceps Size 170 mm
Bone holding forcep Self centering length 239mm
Wire Cutter / Plier 8"
Howman's Retractor Small 10
PFN Next Gen Blade extraction instrument set
Self Centring Forcep - Min
Lateral Mass Instruments Set
Ultra lock Tibia Instrument set with Distal
Instrument set for Pulsar stem
Universal Tibia Instrument set with Distal
Plaster Seezer with Ring
Instrument set for Stellar Cup & Taurus liner System
Health Mallet 250 gms
Bone File
Bone Curettes Medium
Bone holding forcep Self centering length 277mm
Orthopedic manual surgical instrument
Graft Preparation set for ACL-PCL System
Bone Holding Forceps w/Ball ratchet-lock L180
Broken screw removal forcef 10
Tap Sleeve 3.5 mm
Instrument set for Unilock
Patela Bone Holding S/P 8
Broken Screw Removal Set /7
Heygroves Bone Holding 12
Burns Bone Holding Large 10
Flat Nosed Piler Length 160 mm
Muller type Tension Device
Micro Dissection Instrument Set
Bone Taps With Fixed T Handle 3.5 mm [Pitch 1.25 mm)
Heygroves Bone Holding 8
Instrument Set For Cervical Disc Spacer
Spine Dissection Set
Patela Bone Holding D/P 8
Retractor Small
Canulated K Nail Reamer 12 mm
Periosteal Elevator Farabeuf Type Straight
Gigli Saw Wire
Periosleal Elevator S.S. 10''
Mastroid Retractor 150 mm
Self Centring Forcep - Small
Bone Holding Forceps self-center speed-l medium
PFN Next Gen Instrument Set
Reduction Forceps, toothed, speed lock, length 240 mm
Patela Bone Holding S/P 10
Charnuy Retracter
Instrument set for Nova Hip System
Gilpi Retractor large
Bone Nibbler Straight Da 7.5
Drill Sleeves 3.5mm
Kochar's Bone Hook Small
Periosteal Elevator (Robert) 8
Container for rail fixation system
Long Handle Curette & Elevator Set
Reduction Small 6
Lawman Bone Clamp Medium
Howman's Retractor Large 25
VSP Instrument Set
Haygroove Forcep 8"
Ultra Lock Supra Condylar Instrument Set
Instrument Set for Humerus Nail
Bone Holding Self Cenetring forcep Small
Instrument set for Accord Hip System
Bone Taps With Fixed T Handle 6.5mm(Pitch 2.75mm)
Large Fragment Set
ROUNGER KILINER
Bone nibbler double action curved 7
ELASTIC NAIL CUTTER
Periost-Elev straight shaft round edge w
Tap 6.5 mm X 195 mm
AO Type Wire Tightener
Pelvic Reconstruction Plate instrument set
Instrument Set for Daffix
Drill Sleeves 2mm
Self retaining Retractor 12
Mippo Circular Wire passer
Instrument Set For ALFA Pediatric Fixator System
Hammer With Fiber Handle Small
Bone Miller
Anterior Cervical Retractor System
Reduc-Forceps w/Points speed-lock L130
Heygroves Bone Holding 10
Bending Press AO Type
Reduction Forceps, large, with points, L 200mm
K Nail Reamer 9 mm
Bionet correction punch 9''
Instrument set for Fenestrated and Non-Fenestrated Bi-polar
Forceps set for ACL-PCL System
Pediatric wedge
OLECRONA ROUNGER
Establishment Types
Manufacture Medical Device