FDA.reportPublic FDA data

Shukla Xtract-All Spine MKS1031 (Legacy)

Primary DI
B756MMI12230
Brand
Shukla Xtract-All Spine MKS1031 (Legacy)
Company
Shukla Medical
Model
MMI1223
Device description
Driver Assy, Unlock Tool for Seaspine
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B756MMI12230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B756SBLDFLAT130Shukla Blade S9BLADESBLDFLAT-132025-03-25
B756SBLDFLAT140Shukla Blade S9BLADESBLDFLAT-142025-03-25
B756SDR9010Shukla Hip S9HIPSDR9012025-02-14
B756SBLDACE42SP1Shukla Acetabular Cup - S9CUPSBLDACE-42-SP2024-11-07
B756SBLDACE44SP1Shukla Acetabular Cup - S9CUPSBLDACE-44-SP2024-11-07
B756SBLDACE46SP1Shukla Acetabular Cup - S9CUPSBLDACE-46-SP2024-11-07
B756SBLDACE48SP1Shukla Acetabular Cup - S9CUPSBLDACE-48-SP2024-11-07
B756SBLDACE50SP1Shukla Acetabular Cup - S9CUPSBLDACE-50-SP2024-11-07
B756SBLDACE52SP1Shukla Acetabular Cup - S9CUPSBLDACE-52-SP2024-11-07
B756SBLDACE54SP1Shukla Acetabular Cup - S9CUPSBLDACE-54-SP2024-11-07
B756SBLDACE56SP1Shukla Acetabular Cup - S9CUPSBLDACE-56-SP2024-11-07
B756SBLDACE58SP1Shukla Acetabular Cup - S9CUPSBLDACE-58-SP2024-11-07
B756SBLDACE60SP1Shukla Acetabular Cup - S9CUPSBLDACE-60-SP2024-11-07
B756SBLDACE62SP1Shukla Acetabular Cup - S9CUPSBLDACE-62-SP2024-11-07
B756SBLDACE64SP1Shukla Acetabular Cup - S9CUPSBLDACE-64-SP2024-11-07
B756SBLDACE66SP1Shukla Acetabular Cup - S9CUPSBLDACE-66-SP2024-11-07
B756SBLDACE68SP1Shukla Acetabular Cup - S9CUPSBLDACE-68-SP2024-11-07
B756SBLDACE70SP1Shukla Acetabular Cup - S9CUPSBLDACE-70-SP2024-11-07
B756SBLDACE72SP1Shukla Acetabular Cup - S9CUPSBLDACE-72-SP2024-11-07
B756SBD0080Shukla Knee S9KNEESBD008SBD0082020-11-16

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