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
- [email protected]
- Phone
- 208 8616488
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2020-09-17 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2020-09-17 |
| Fork | HXE | Class 1 | Orthopedic | No | 2021-12-13 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2021-12-13 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2021-12-13 |
| Template | HWT | Class 1 | Orthopedic | No | 2021-12-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-02-28 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2020-09-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-13 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-12-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-12-13 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2025-07-02 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2018-10-30 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2024-02-28 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2021-12-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-10-30 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2026-02-03 |
| Bender | HXW | Class 1 | Orthopedic | No | 2020-09-17 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2020-09-17 |
| Probe | HXB | Class 1 | Orthopedic | No | 2021-12-13 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2021-12-13 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2020-09-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-02-10 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2020-09-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2020-05-13 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2026-02-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-09-17 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2025-07-02 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2021-12-13 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-09-17 |
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)