FDA.reportPublic FDA data

ACCESSORY CONN. M10

Primary DI
08057968716827
Brand
ACCESSORY CONN. M10
Company
HPF SRL
Model
H0034000329
Published
2022-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08057968716827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968716827080579687168278057968716827

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

Regulatory Flags#

DUNS number
895802853
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057968716742MIS 4.0 REAMER HANDLE CUP IMPACTORH00340000992022-09-08
08055727375285DROP HANDLE M8 BLUEH15000002092022-09-05
08055727375322DROP HANDLE CANNULATED M8 VIOLETH15000202192022-09-05
08055727375339DROP HANDLE CANNULATED M8 NIGHT BLUEH15000502192022-09-05
08055727375346DROP HANDLE CANNULATED M8 BLUEH15000002192022-09-05
08055727375353DROP HANDLE CANNULATED M8 BLACKH15000102192022-09-05
08055727375360"T" RATCHED HANDLE YELLOWH15000404092022-09-05
08055727375377"T" RATCHED HANDLE WHITEH15000304092022-09-05
08055727375384"T" RATCHED HANDLE VIOLETH15000204092022-09-05
08055727375391"T" RATCHED HANDLE NIGHT BLUEH15000504092022-09-05
08055727375407"T" RATCHED HANDLE CANNULATED NIGHT BLUEH15000504592022-09-05
08055727375414"T" RATCHED HANDLE CANNULATED YELLOWH15000404592022-09-05
08055727375421"T" RATCHED HANDLE CANNULATED WHITEH15000304592022-09-05
08055727375438"T" RATCHED HANDLE CANNULATED VIOLETH15000204592022-09-05
08055727375445"T" RATCHED HANDLE CANNULATED BLUEH15000004592022-09-05
08055727375452"T" RATCHED HANDLE CANNULATED BLACKH15000104592022-09-05
08055727375469"T" RATCHED HANDLE BLUEH15000004092022-09-05
08055727375476"T" RATCHED HANDLE BLACKH15000104092022-09-05
08055727375483"T" HANDLE M8 YELLOWH15000401592022-09-05
08055727375490"T" HANDLE M8 WHITEH15000301592022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311258185Fusion Lateral Instrument SetXtant Medical Holdings, Inc.HWA2026-10-23
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