FDA Registration
Active
🇺🇸 United States
S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
Reg #: 2249418
·
FEI: 2183899
·
Expires 2026
Products
17
Proprietary Names
63
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL
- Registration Number
- 2249418
- FEI Number
- 2183899
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8300 Sheen Drive
- City
- St Petersburg
- State
- FL
- ZIP
- 33709
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-07-06 |
| 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 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-12-13 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2022-11-14 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-25 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-02-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-02-25 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-02-25 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2023-06-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-02-25 |
| Bender | HXW | Class 1 | Orthopedic | No | 2024-01-15 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-02-25 |
Proprietary Names
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
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
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)
Shukla Blade - Universal Flexible Osteotome System (S9SHLDR-BLADE)
PRETENSIONER
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility