FDA Registration Active 🇮🇳 India

INDIUS MEDICAL TECHNOLOGIES PVT. LTD.

Reg #: 3014938863 · FEI: 3014938863 · Expires 2026
Products
30
Proprietary Names
214
Establishment Types
4
Classifications
30

Registration Details

Registration Name
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
Registration Number
3014938863
FEI Number
3014938863
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Unit No.12, Electronic Co-operative Estate, Pune - Satara Road
City
Pune Maharashtra
Country
IN

Regulatory Submissions

510(k) Number
K200937

Owner / Operator

Firm Name
Indius Medical Technologies Pvt. Ltd.
Operator Number
10058793
Address
Unit 12, Floors 1 and 2, Electronic Co-operative Estate, Pune - Satara Road
City
Pune
State
Maharashtra
Postal Code
411009
Country
IN

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
Accessories, Fixation, Spinal Intervertebral Body LYQ
Curette HTF
Fork HXE
Pusher, Socket HXO
Positioner, Socket KIL
Template HWT
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Osteotome HWM
Appliance, Fixation, Spinal Interlaminal KWP
Appliance, Fixation, Spinal Intervertebral Body KWQ
Thoracolumbosacral Pedicle Screw System NKB
Mallet HXL
Instrument, Compression HWN
Sacroiliac Joint Fixation OUR
Wrench HXC
Orthopedic Manual Surgical Instrument LXH
Guide, Needle, Surgical GDF
Bender HXW
Retractor GAD
Probe HXB
Tap, Bone HWX
Awl HWJ
Tray, Surgical, Instrument FSM
Holder, Needle; Orthopedic HXK
Tamp HXG
Extractor HWB
Screwdriver HXX
Starter, Bone Screw HWD
Cutter, Wire HXZ
Bit, Drill HTW

Proprietary Names

CURETTE Fork (Spine Retraction) Rod Lever/ Reduction Fork Hook Pusher Rod Pusher Screw Head Positioner Rod Template OSTEOTOME Parallel Compressor - long throw Parallel Compressor (non ratcheting) INSTRUMENT, COMPRESSION Parallel Compressor- Distractor, Cannulated Screw Parallel Compressor MIS Compressor Long Tab Compressor Rod Inserter Wrench Tower reducer Wrench Tower clip reducer hex wrench Hex wrench Dilator -1 Angled Rod Inserter (MIS) PLIF/O-LIF L-Inserter Rod Lever Angled Plunger C-C Derotator Connection: Short Lumbar Trocar Screw confirmation tool C-C Derotator Connection: Long Tower Reducer Sleeve Tower Reducer Shaft Ratcheting quick connect T handle Threaded attachments- M4 Ratchetting Reducer NT Forth Dilator Rod Inserter Threaded Shaft Long Trocar Locking Cap Guide Long tab remover Ratcheting quick connect straight handle Rod Calliper Tower Reducer NT Blade 10mm (Spine Retractor) Pedicle Finder Torque limiting quick connect T handle (5_5 Nm) M-L Derotator Connection: Long Reducer Extension Tube First Dilator Overhead reducer NT Tower Clip Reducer (wire cut) Reducer attachment Lateral Reducer Orthopedic manual surgical instrument K wire Pin Self-Retaining Sleeve Clamp (Spine Retractor) In Situ Distraction device Blade 20mm (Spine Retractor) Counter Torque Rod Inserter, Separate incision Parallel Distractor - long throw Cross Connector Inserter Straight Cannulated Ratchetting Handle Second Dilator Overhead reducer Vertebral body cavity creation instrument, large Alignment Instrument: Prongs Holder: Inner Shaft Assembly Long sleeve/ Locking cap guide Vertebral body cavity creation instrument, small Counter Torque NT Vertebral body cavity creation instrument, medium Torque limiting quick connect T handle (8 Nm) Tower Clip Reducer Ratcheting quick connect T handle Cannulated Threaded attachments- M8 Third Dilator Locking Cap Guide NT Lamina Finder Drill Guide: Sliding Counter torque- Reduction Screw Jig for 1 Level Plate Cement Delivery Cannula Transverse Process Finder Cross Connector Calliper Ratchetting Reducer Tower Reducer Candle Stick Rod Lever NT Rotational Quick Connect Handle Rod Inserter, Flexible M-L Derotator Connection Parallel Distractor (non ratcheting) Parallel Distractor Threaded attachments- M6 Counter Torque, Long Tab Screw Long Reducer Rod Confirmer Rod Inserter Sleeve Alignment Instrument Prongs Assembly Counter Torque, Cannulated Screw Anti-Splay Sleeve Tab Breaker Vice Grip Alignment Instrument: Prongs Holder: Outer Hex Tube M-L Derotator Connection: Short Custom Paddle Distractor Flanged Connector Guide Ratcheting Quick Connect Handle ( Black) Long Tab Cutter Dilator -2 Screwhead Tube (C/D) Fulcrum Sleeve PLIF/O-LIF Threaded Rod L-Inserter Long Tab Distractor Long Tab Breaker Dilator-3 MIS Distractor Rod Inserter (MIS) Rod Caliper Double Action Cutter Access Needle BENDER In Situ Bender Left Coronal bender right Rod Bender Rod Bender (Small) Coronal bender left In Situ Bender Right French Rod Bender Midline Retractor RETRACTOR Retractor (Spine Retractor) Soft Tissue Retractor Thoracic Probe Ball Tip Probe Dia 2.5 probe (M) Medium Ball tip probe Curved Ball Tip Probe Scoop like pedicle probe Ball Tip Probe, Large Curved Lenke Probe (Large) Short Thoracic probe Small Ball tip probe Double Ended Probe Ball Tip Probe - Lateral Mass Curved Lenke Probe Dia 2.5 probe (L) Straight Lenke probe 8.5 mm tap (Straight) Cannulated Tap dia 6.5 mm 7.5 mm tap (Straight) 6.5 mm tap (Straight) 8.5 mm Tapered Tap 4 mm tap (Straight) 4.5 mm tap (Straight) 6.5 mm Tapered Tap 4.5 mm Tapered Tap 4 mm Tapered Tap Cannulated Tap dia 5.5 mm 5.5 mm Tapered Tap 7.5 mm Tapered Tap 5.5 mm tap (Straight) Cannulated Tap dia 4.5 mm AWL Tapered Awl ACURA-MIS Stabilization System Instrument Case Instrument Case ACURA-MIS Stabilization System Implants Case Implant and Instrument Case assmbly Implant Case NT Locking Cap Case ACURA-MIS Stabilization System Implants and Instruments Case Flanged Connector Case Implant Case assembly Locking Cap Case Instrument Case assembly Implant and Instrument Case Wide Holder: Assembly Access Needle (11 Gauge) Offset Hook Holder Rod Holder- small Rod Holder Standard Hook Holder HOLDER, NEEDLE; ORTHOPEDIC Access Needle (8 Gauge) TAMP Guidewire Extractor Locking Cap Driver- Straight Handle (MIS) T20 Connector Driver ( Silicone Handle) Rigid Driver - Long Tab Final Tightening Driver (NT) Cap Driver Driver with Sleeve Cap Driver - Reduction Screw Locking Cap driver, Knurled Standard Driver T10 Solid T10 Self - Retaining Driver SCREWDRIVER Self-Retaining Driver Cross Connector driver, T10 T 20 Connector driver Cross Connector Driver, T15 Final Tightening Driver Self – Retaining Driver T10 Locking Cap driver, Quick connect Self – Retaining Driver T20 T-40 Driver Ratchet Driver Set Screw Starter- Double Sided Guide Wire Rod Cutter Guide Wire ( Non-threaded) Guide Wire ( Threaded) BIT, DRILL Drill 2.2 mm

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)