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
Phone
208 8616488

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

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