FDA.reportPublic FDA data

FOREFOOT SOLUTIONS™

Primary DI
M248119309ND1
Brand
FOREFOOT SOLUTIONS™
Company
NEWDEAL
Model
119309ND
Device description
The staple impactor is used to impact the staples to ensure that thay are flush with the bone surface.
Published
2017-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780045915PrimaryGS10
M248119309ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004591510381780045915

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780357490K-FIX®119050ND2020-11-23
10381780045687K-WIRE115071ND115071ND2017-10-09
10381780045731K-WIRE115110ND115110ND2017-10-09
10381780045755K-WIRE115111ND115111ND2017-10-09
10381780045786K-WIRE115170ND115170ND2017-10-09
10381780045809K-WIRE115171ND115171ND2017-10-09
10381780045847K-WIRE115316ND115316ND2017-10-09
10381780045854K-WIRE115416ND115416ND2017-10-09
10381780041771QWIX®119932ND2017-05-26
10381780042099Hallu®-FIX129930ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886914771Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914801U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914818U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914825U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914832U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914849U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914856U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914863U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915471Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915488Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915495Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
00190776434694MillenniumAvalign Technologies, Inc.HWA2026-10-12
00889795151735APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151742APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151759APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00190776433789MillenniumAvalign Technologies, Inc.HWA2026-10-08
09421028119184Enztec Partial Knee Femoral Impactor - Angled ArmENZTEC LIMITEDHWA2026-10-07
09421028119191Enztec Partial Knee Femoral Impactor with Slap Hammer - Angled ArmENZTEC LIMITEDHWA2026-10-07
00190446982623DJO SURGICALEncore Medical, L.P.HWA2026-09-30
07640187918816Ortho Development Offset Cup Impactor, 5/16-24 UNF x 3.94MPS Micro Precision Systems AGHWA2026-09-27
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
03701089527934AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527941AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527958AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089528450AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089547512AMPLITUDEAMPLITUDE SASHWA2026-07-29
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
00822409135721N/AOrtho Development CorporationHWA2026-07-16