FDA.reportPublic FDA data

Main-Mallet-Spinal Simplicity

Primary DI
B908350011000
Brand
Main-Mallet-Spinal Simplicity
Company
Mainstream Medical Devices, LLC
Model
316-35-911
Catalog number
35-0011-000
Device description
"Single-Use, Surgical Mallet, Slotted, 8"" Small Contoured Handle, 16oz Head Weight, Spinal Simplicity, Sterile"
Published
2025-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXLMallet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B908350011000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Weight1Pound

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
512-289-3437dana.wilcox@mainstreammedicaldevices.com

Regulatory Flags#

DUNS number
071513432
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90829211908Main-AXS Needle-Retropsoas292-11-908292-11-9082025-04-30
B90830825080Main-Mallet308-25-080308-25-0802025-04-04
B90831225080Main-Mallet312-25-080312-25-0802025-04-04
B90831625080Main-Mallet316-25-080316-25-0802025-04-04
B90831635080Main-Mallet316-35-080316-35-0802025-04-04
B908350008000Main-AXS Needle-Spinal Simplicity292-11-92035-0008-0002024-12-03
B908350009000Main-AXS Needle-Spinal Simplicity299-08-90035-0009-0002024-12-03
B90831020150Sterile Drill Bit310-20-150310-20-1502024-08-09
B90831020150907Sterile Drill Bit - RMR310-20-150-90707.20.QDS2024-08-09
B90831025150Sterile Drill Bit310-25-150310-25-1502024-08-09
B90831027150Sterile Drill Bit310-27-150310-27-1502024-08-09
B90831027150907Sterile Drill Bit - RMR310-27-150-90707.27.QDS2024-08-09
B90831032150Sterile Drill Bit310-32-150310-32-1502024-08-09
B90831032150907Sterile Drill Bit - RMR310-32-150-90707.32.QDS2024-08-09
B9081600051Main-Knife RIGID 21mm, Alphatec451-25-9011600-052024-03-02
B9081600060Main-Knife - Alphatec471-25-9011600-062024-03-02
B90847125901Main-Knife - Alphatec471-25-9011600-062024-02-21
B90845125901Main-Knife RIGID 21mm, Alphatec451-25-9011600-052023-07-12
B90847125193Main-Knife - Alphatec471-25-193471-25-1932024-02-21
B90847135193Main-Knife - Alphatec471-35-193471-35-1932024-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14
03662663129831Disc Preparation InstrumentsHighridge Medical, LLCHXL2025-11-14
03662663109239Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHXL2025-11-12
03662663109703Mergence-A Preparation InstrumentationHighridge Medical, LLCHXL2025-11-12
00810074308748250mm MalletOsteocentric Technologies, Inc.HXL2025-10-21
00810135963657ImpactNVISION BIOMEDICAL TECHNOLOGIES, INC.HXL2025-09-24
00810189110526MALLETOsteocentric Technologies, Inc.HXL2025-09-22
B382SD914554370Surgical DirectSurgical Direct, Inc.HXL2025-09-12
B382SD91455610310Surgical DirectSurgical Direct, Inc.HXL2025-09-12
00840314269812gSourceGSOURCE LLCHXL2025-08-29
00850078230041Disruptive MedTechMAHE MEDICAL USA LLCHXL2025-08-14
00757770423750Bausch + LombBausch & Lomb IncorporatedHXL2025-08-08