Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2249418

FEI Number

2183899

Entity Name

S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL

City/State/Country

St Petersburg, FL, US

Establishment Address

8300 Sheen Drive, St Petersburg, FL 33709, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL (Owner Number: 9035854)

Owner / Operator Contact Address

8300 Sheen Drive, --, St Petersburg, FL 33709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-07-06
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2013-02-25
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-25
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-02-25
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-12-13
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2022-11-14
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-02-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2013-02-25
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-02-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-25
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-02-25
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2013-02-25
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-02-25
HWK	Trephine	Orthopedic	Class 1	888.4540	2023-06-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-02-25

Official Correspondent

Subra Naglapura

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011365613	S. S. White Technologies India Pvt. Ltd.	Surendranagar Gujarat, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249418. Last updated year: 2026. Please use registration number 2249418 when referencing this establishment in official correspondence.