FDA Registration
Active
🇮🇳 India
Trial 10 mm
Reg #: 3038187464
·
FEI: 3038187464
·
Expires 2025
Products
1
Proprietary Names
161
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIRACLUS ORTHOTECH PRIVATE LIMITED
- Registration Number
- 3038187464
- FEI Number
- 3038187464
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Survey No 106, Village Vavdi, Opp Safex Industries, Behind Elite Boarding School, Vavdi, Ta. Kheda
- City
- Ahmedabad Gujarat
- Country
- IN
Owner / Operator
- Firm Name
- Miraclus Orthotech Private Limited
- Operator Number
- 10093149
- Address
- Survey No 106, Village Vavdi, Opp Safex Industries, Behind Elite Boarding School, Vavdi, Ta. Kheda
- City
- Ahmedabad
- State
- Gujarat
- Postal Code
- 387550
- Country
- IN
- Correspondent
- Hardik Kakadiya
US Agent
- Business Name
- mdi Consultants. Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2025-04-07 |
Proprietary Names
Trial 10 mm
Trial Spacer 12 mm
Trial 9 mm
Stand For Alignment Rod ( Small )
TLIF Cage Intruducer
Opening Wedge Measuring Instrument
Trial 13 mm
DilatatorDia 6 mm
Trial 14 mm
T-Handle
Connecting Screw For Aiming Device-Small
Connecting Screw Connector For Insertion Handle
Trial Spacer 9 mm
DilatatorDia 17.8
1.5 Nm Torque Limiting Handle
Flexible Arm Attachment
Dia 6.4 mm Stoper Drill Bit For Recon Screw
Angle Guide 130°
Rod Griper
Torque Limiting Attachment, 1.2 Nm
Sharp Bone Hook-Large Length 230 With T- Handle
Ratchat Handle
Soft Tissue Protector
Torque Limiting Screw Driver(0.8 N.M)
Bridge
Cage Trial 14*H5
Dia2.5 Cannulated Screw Measuring Device
Tissue Protector
Multifunction Rod For Insertion Instrument
Table Attachment
Tissue Protecion Sleeve
Connical Bolt
Screw For Aiming Jig
Tention Device Dia4
Torque Limiting With Quick Coupling , 1.2 Nm
Straight Q.C Handle
Spike-Straight With Sharp Ball Tip 300 mm Length
Percutaneous Arm 255 mm
Cage Trial 14*H6
Curved Spike
Trial 7 mm
Radiographic Scale
Torque Limiting T-Handle
Straight Handle With Quick Coupling
Locking Nut For Aiming Jig
Conical Bolt
Radio Graphic Scale Measuring Nail
Radiographic Scale For Simple Tibia
Adapter Quick Coupling
Dia7x480mm
Blade Widener
Alignment Rod
12 Nm Torque Limiting Handle
Handle For Torque Limitator4 N.M
Stand For Alignment Rod ( Large )
Sharp Hook
Straight-Handle With AO- Q.C
Gap Measuring Device
Connecting Bolt For Connecting Nail With Insertion Handle
Cage Trial 14*H8
Flexible Shaft
Universal T - Handle
Dia8x480mm
Extender
Radiographic Scale For PFA
Flat Spike
Compression Sleeve Attchment Quick Coupling
Lamina Preparator
Trial Spacer 8 mm
Trial Spacer 10 mm
DilatatorDia 15
T-Handle With AO-Q.C
Sharp Bone Hook-Medium Length 200
0.8 Nm Torque Limitor
Cage Implant Footprint 14/16 mm
DilatatorDia 13 mm
Compression Nut
Quick Coupling
Torque Screwdriver
Connecting Screw For PFA For Insertion Handle
0.4 Nm Torque Limiting Handle
DilatatorDia 19 mm
ASLP Reduction Attachment
DilatatorDia 15 mm
Head Aligner
4 Nm Torque Limiting
Distractor
Compression Nut For Lag Screw
Compressor & Distractor
Quick Coupling T-Handle
Quick Coupling Torque Limiting Handle 4 Nm
Trial 11 mm
Connecting Screw For Carben Fiber Zig
Handle For Torque Limiting
Dia 6.4 mm Stoper Drill Bit For Recon Screw Cannulated
DilatatorDia 21mm
Straight Quick Coupling Handle
Adapter
Trial Spacer 5 mm
Quick Coupling Torque Limiting Handle 1.5 Nm
4 Nm Torque Limiting Handle
Quick Coupling Shaft T8
Tension Device Dia3
T-Handle Q.C
T-Handle For Proximal Cannulated Drill
Torque Limited Head
Quick Coupling T Handle
Hohmann-Shape Arm 183 mm
Trial Spacer 7 mm
Torque Limiting Screw Driver(1.5 N.M)
Pin Distractor
DilatatorDia 9.4
Connecting Screw For Proximal Aiming Jig
Rachet Handle
Measuring Device For Locking Bolt
T Handle With Quick Coupling
Stand For Alignment Rod ( Straight )
Pelvic Arm 225 mm
Quick Coupling Hande
Plate Cutting Clamp
Trial Spacer 6 mm
Torque Limiting Handle
Direct Measuring Device For Guide WiresDia3.2 mm
Trial 12 mm
DilatatorDia 17 mm
Connecting Screw For Insertion Handle
Cage Trial 14*H7
Rod Reducer
Spiked Disc
Trial Spacer 11 mm
Quick Coupling Handle For 2.4 mm System
Ratchet Handle
Connecting Screw For Proximal Aiming Device
Torque Limiting Driver 1.5 Nb
DilatatorDia 10 mm
Cage Implant Footprint 10/12 mm
Direct Measuring Device For Guide Wire 3.2 mm Dia
Quick Coupling Handle
0.8 Nm Torque Limiting Handle
Cage Trial 14*H4
Connecting Screw For Insrtion Handle
Trial 8 mm
T-Handle With Quick Coupling
Connecting Screw
Final Tightener
Cutting Clamp
Reduction Attachment
Guide Pin Detectors
Compression Screw
Pressure Hook
Q.C. T-Handle For Proximal Reamer
Quick Coupling Handle For 1.5 & 2 mm System
Connecting Bolt
Collinear Reduction Clamp (Sliding Mechanism)
Compression Bolt
Handle With Quick Coupling
Dilatator Dia 5.3
Extracting Handle With Connecting Bolt
Quick Coupling Torque Limiting Handle 0.8 Nm
Measuring Device
Reduction Clamp With Point
Establishment Types
Manufacture Medical Device