FDA.reportPublic FDA data

Shukla Blade S9BLADE

Primary DI
B756SBLDFLAT17020
Brand
Shukla Blade S9BLADE
Company
Shukla Medical
Model
SBLDFLAT-17-02
Device description
Blade, Flat, Posterior Lateral, Knee, 25 mm x 12 cm, Single Use
Published
2026-07-09
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B756SBLDFLAT17020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, single-useA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1-888-474-8552CS@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
B756SBLDFLAT17010Shukla Blade S9BLADESBLDFLAT-17-012026-07-09
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
B756STP159020Shukla Universal Modular Vise Grip SystemSTP159-022026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435516MillenniumAvalign Technologies, Inc.HWM2026-10-20
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00190776435592MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776437671MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437732MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437817MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776435127MillenniumAvalign Technologies, Inc.HWM2026-10-15
00190776435134MillenniumAvalign Technologies, Inc.HWM2026-10-15
00840277133915Innomed, Inc.INNOMED, INC.HWM2026-10-09
00190776434007MillenniumAvalign Technologies, Inc.HWM2026-10-08
00190776436261MillenniumAvalign Technologies, Inc.HWM2026-10-08
G141548807040Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141548807060Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141549966080Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141646640020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.HWM2026-10-06
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29
00190776432713MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432720MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432737MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431020MillenniumAvalign Technologies, Inc.HWM2026-09-18