FDA.reportPublic FDA data

Shukla Acetabular Cup - S9CUP

Primary DI
B756SBD204410
Brand
Shukla Acetabular Cup - S9CUP
Company
Shukla Medical
Model
SBD204-41
Device description
Centering Bob 41mm
Published
2023-09-13
Public version status
Update
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
B756SBD204410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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

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Primary DI, Brand, Company table
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00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
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20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
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00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03