Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014938863

FEI Number

3014938863

Entity Name

INDIUS MEDICAL TECHNOLOGIES PVT. LTD.

City/State/Country

Pune Maharashtra, IN

Establishment Address

Unit No.12, Electronic Co-operative Estate, Pune - Satara Road, Pune Maharashtra 411009, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Indius Medical Technologies Pvt. Ltd. (Owner Number: 10058793)

Owner / Operator Contact Address

Unit 12, Floors 1 and 2, Electronic Co-operative Estate, Pune - Satara Road, Pune, IN-MH 411009, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2020-09-17
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2020-09-17
HXE	Fork	Orthopedic	Class 1	888.4540	2021-12-13
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2021-12-13
KIL	Positioner, Socket	Orthopedic	Class 1	888.4540	2021-12-13
HWT	Template	Orthopedic	Class 1	888.4800	2021-12-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-02-28
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2020-09-17
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-12-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-12-13
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2025-07-02
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2018-10-30
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-02-28
HXC	Wrench	Orthopedic	Class 1	888.4540	2021-12-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-09-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-10-30
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-02-03
HXW	Bender	Orthopedic	Class 1	888.4540	2020-09-17
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2020-09-17
HXB	Probe	Orthopedic	Class 1	888.4540	2021-12-13
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2021-12-13
HWJ	Awl	Orthopedic	Class 1	888.4540	2020-09-17
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

Premkumar Babu Business: Premkumar Reddy Medical, USA LLC Email: medical@prem4biz.com Phone: (208) 8616488

Related Public Records

Same Entity

Indius Medical Technologies Pvt. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3027726367	HAPPE SPINE	Grand Rapids, MI, US
3017435639	ARTFX MEDICAL LLC	JAX, FL, US
3011513267	FLOSPINE LLC	Boca Raton, FL, US
3007604895	HC BIOLOGICS LLC	Miami, FL, US
3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	KADI Gujarat, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014938863. Last updated year: 2026. Please use registration number 3014938863 when referencing this establishment in official correspondence.