FDA Registration
Active
🇮🇳 India
S. S. White Technologies India Pvt. Ltd.
Reg #: 3011365613
·
FEI: 3011365613
·
Expires 2026
Products
16
Proprietary Names
62
Establishment Types
3
Classifications
16
Registration Details
- Registration Name
- S. S. White Technologies India Pvt. Ltd.
- Registration Number
- 3011365613
- FEI Number
- 3011365613
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SURVEY NO. 2788/3,WADHWAN-AHMEDABAD HIGHWAY, NEAR KRISHNA PETROL PUMP,
- City
- Surendranagar Gujarat
- Country
- IN
Owner / Operator
- Firm Name
- S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
- Operator Number
- 9035854
- Address
- 8300 Sheen Drive, --
- City
- St Petersburg
- State
- FL
- Postal Code
- 33709
- Country
- US
- Correspondent
- Subra Naglapura
US Agent
- Business Name
- S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
- Contact Name
- Subra Naglapura
- Address
- 8300 Sheen Drive, --
- City
- St Petersburg
- State
- FL
- ZIP
- 33709
- Country
- US
- [email protected]
- Phone
- 727 6262802
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2022-11-14 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-12-13 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-02-25 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-02-25 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-02-25 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2023-06-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-07-06 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-02-25 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
Proprietary Names
BIG MALLET
SLOTTED DEAD BLOW MALLET
Slotted Mallet
LARGE HANDLE MALLET
Removal System, Spine, Cervical and Instrument Tray V4 (S9SPINE-C)
Removal System, Spine, Cervical, Thoracic Lumbar and TWO Instrument Trays V4 (S9SPINE-PLUS)
Removal System, Spine, Legacy (MKS1031)
Xtract-All Spine Helicopter Socket Set
Removal System, Spine, Thoracic Lumbar and Instrument Tray V4 (S9SPINE-TL)
Removal System, Spine, Cervical, Thoracic Lumbar and Instrument Tray V4 (S9SPINE)
ScrewFlex
Removal System, Helicopter Socket Set for Spine (S9COPTER)
Broken and Stripped Screw (S9ScrewFlex)
Extraction System, Knee (S9KNEE)
Xtract-All Hip Stem Extraction System
Maxi Ratcheting Screwdriver System
CTL Total Spine System
Removal System, Femoral Lag Screw (S9LAG)
Xtract-ALL Anterior Hip
Shukla Medical, Inc.
Mini Ratcheting Screwdriver System
Extraction System, Modular Hip (S9HIP-MOD)
Xtract-All CORE Rigid Trephine System
Removal System, Screw, Broken & Stripped V3 System Name: Broken & Stripped V3 (S9SCREW)
Blade System, Osteotome, Flexible (S9BLADE)
Avascular Necrosis Core Decompression
Removal System, Screw, Broken & Stripped V2, Extractors 2 sets, No Drill Bits (S9SCREW-SE)
Xtract-All Screw Universal Broken & Stripped Screw Extraction System
Xtract-All Knee Universal Knee Implant Extraction System
Winquist III Universal IM Nail Extraction System
Shukla Anterior Hip - S9HIP-ANT
Extraction System, IM Nail, Broken (S9NAIL-BR)
Removal System, Screw, Maxi, Large Bone Screw V3: Rigid Drivers Only (S9MAXI-E)
Removal System, Screw, Legacy, Broken & Stripped Extractors 4 each (MKS1022)
Xtract-All Osteotome Universal Flexible Osteotome System (S9FLEX)
Extract-All Cement Universal Bone Cement Extraction System
Extraction System, Hip (S9HIP)
Extraction System Hip, Economic (S9HIP-E)
Removal System, Screw, Maxi, Large Bone Screw V3 (S9MAXI)
Xtract-All Screw V.2 Universal Broken & Stripped Screw Extraction System
Extraction System, IM Nail V4 (S9NAIL)
Power Driver for Mini Ratcheting Screwdriver System
Removal System, Screw, Maxi, Large Bone Screw Legacy (MKS1029)
Winquist 4 Universal IM Nail Extraction System
Removal System, Screw, Legacy, Broken & Stripped: Surgery Center Set Extractors 2 each (MKS1022-E)
Shukla Shoulder - Universal Shoulder Implant Extraction System (S9SHLDR)
Removal System, Screw, Mini, Small Bone Screw V4 (S9MINI)
Removal System, IM Nail, Winquist 3, Legacy (MKS1017)
Xtract-All Anterior Hip
Universal Broken, Stripped and Seized Screw Extraction Syste
Removal System, Screw, Broken & Stripped V2 Extractors 4 each, No Drill Bits (S9SCREW-E)
Shukla Acetabular Cup Removal System S9ACE
Shukla Maxi Trauma System S9MAXI-TRMA
Shukla Elbow Implants Removal System S9ELBW
Universal Vise Grip System S9VISE
Shukla Blade - Universal Flexible Osteotome System (S9SHLDR-BLADE)
TIP, CARBIDE DRILL BIT, 3MM, Single Use
TIP, CARBIDE DRILL BIT, 5MM, Single Use
TIP, CARBIDE DRILL BIT, 6MM, Single Use
TIP, CARBIDE DRILL BIT, 4MM, Single Use
TIP, CARBIDE DRILL BIT, 2MM, Single Use
TIP, CARBIDE DRILL BIT, 7MM, Single Use
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device