FDA Registration
Active
🇮🇳 India
Removal System, Screw, Legacy, Broken & Stripped: Surgery Center Set Extractors 2 each (MKS1022-E)
Reg #: 3011365613
·
FEI: 3011365613
·
Expires 2025
Products
1
Proprietary Names
42
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- S. S. White Technologies India Pvt. Ltd.
- Registration Number
- 3011365613
- FEI Number
- 3011365613
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-12-13 |
Proprietary Names
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, Legacy, Broken & Stripped Extractors 4 each (MKS1022)
Extraction System, Knee (S9KNEE)
Extraction System Hip, Economic (S9HIP-E)
Extraction System, Modular Hip (S9HIP-MOD)
Removal System, Screw, Mini, Small Bone Screw V4 (S9MINI)
Winquist III Universal IM Nail Extraction System
Winquist 4 Universal IM Nail Extraction System
Xtract-All Osteotome Universal Flexible Osteotome System (S9FLEX)
Shukla Anterior Hip - S9HIP-ANT
Extraction System, IM Nail, Broken (S9NAIL-BR)
Blade System, Osteotome, Flexible (S9BLADE)
Removal System, Screw, Maxi, Large Bone Screw V3: Rigid Drivers Only (S9MAXI-E)
Shukla Maxi Trauma System S9MAXI-TRMA
Removal System, Screw, Broken & Stripped V2, Extractors 2 sets, No Drill Bits (S9SCREW-SE)
Avascular Necrosis Core Decompression
Xtract-All Knee Universal Knee Implant Extraction System
Extraction System, IM Nail V4 (S9NAIL)
Power Driver for Mini Ratcheting Screwdriver System
Removal System, IM Nail, Winquist 3, Legacy (MKS1017)
Removal System, Screw, Maxi, Large Bone Screw Legacy (MKS1029)
Xtract-All CORE Rigid Trephine System
Xtract-All Anterior Hip
Xtract-All Screw V.2 Universal Broken & Stripped Screw Extraction System
Shukla Medical, Inc.
Extract-All Cement Universal Bone Cement Extraction System
Removal System, Screw, Maxi, Large Bone Screw V3 (S9MAXI)
Xtract-All Hip Stem Extraction System
CTL Total Spine System
Removal System, Femoral Lag Screw (S9LAG)
Extraction System, Hip (S9HIP)
Maxi Ratcheting Screwdriver System
Xtract-ALL Anterior Hip
Xtract-All Screw Universal Broken & Stripped Screw Extraction System
Universal Broken, Stripped and Seized Screw Extraction Syste
Removal System, Screw, Broken & Stripped V2 Extractors 4 each, No Drill Bits (S9SCREW-E)
Removal System, Screw, Broken & Stripped V3 System Name: Broken & Stripped V3 (S9SCREW)
Mini Ratcheting Screwdriver System
Universal Vise Grip System S9VISE
Shukla Acetabular Cup Removal System S9ACE
Shukla Elbow Implants Removal System S9ELBW
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)