FDA.reportPublic FDA data

Shukla Knee S9KNEE

Primary DI
B756SXT0020
Brand
Shukla Knee S9KNEE
Company
Shukla Medical
Model
SXT002
Device description
Extractor Assy, Femoral Component
Published
2020-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B756SXT0020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vice gripA heavy-duty, hand-held, surgical instrument with specially designed sturdy handles and gripping jaws intended to be used to securely grip around or hold an object during a surgical intervention. It is made of high-grade stainless steel and is designed like an adjustable wrench and has handles that are self-locking when squeezed closed. The jaws are strong, typically having a concave grip with heavy serrations, and are pivoted with an adjustable ratio-lever exchange to achieve the optimum gripping aperture and gripping force. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1-727-626-2770CS@ShuklaMedical.com

Regulatory Flags#

DUNS number
159009294
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B756SBLDFLAT17010Shukla Blade S9BLADESBLDFLAT-17-012026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADESBLDFLAT-17-022026-07-09
B756007053001000Torque Wrench00705300100007053001002026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mm00705300200007053002002026-06-01
B756STP071010Shukla Universal Modular Vise Grip SystemSTP071-012026-05-18
B756STP071020Shukla Universal Modular Vise Grip SystemSTP071-022026-05-18
B756STP072010Shukla Universal Modular Vise Grip SystemSTP072-012026-05-18
B756STP072020Shukla Universal Modular Vise Grip SystemSTP072-022026-05-18
B756STP073010Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP073020Shukla Universal Modular Vise Grip SystemSTP073-022026-05-18
B756STP0740Shukla Universal Modular Vise Grip SystemSTP0742026-05-18
B756STP0750Shukla Universal Modular Vise Grip SystemSTP0752026-05-18
B756STP0760Shukla Universal Modular Vise Grip SystemSTP0762026-05-18
B756STP0770Shukla Universal Modular Vise Grip SystemSTP0772026-05-18
B756STP0780Shukla Universal Modular Vise Grip SystemSTP0782026-05-18
B756STP0820Shukla Universal Modular Vise Grip SystemSTP0822026-05-18
B756STP0830Shukla Universal Modular Vise Grip SystemSTP0832026-05-18
B756STP0840Shukla Universal Modular Vise Grip SystemSTP0842026-05-18
B756STP0850Shukla Universal Modular Vise Grip SystemSTP0852026-05-18
B756STP0860Shukla Universal Modular Vise Grip SystemSTP0862026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
00889929072219NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072226NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072233NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072264NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072271NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072288NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072295NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072301NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072318NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072325NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072332NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072349Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072356NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072363NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072394NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCLXH2026-07-17
00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17