FDA.reportPublic FDA data

BENCOX Surgical Instruments

Primary DI
08806373888038
Brand
BENCOX Surgical Instruments
Company
Corentec Co., Ltd
Model
01.51.771.02
Device description
Impacting Part 32mm
Published
2025-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08806373888038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373888038088063738880388806373888038

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82269374902ra@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809945895311EXULT Special Instrument(CM)KZ.026.Z0032026-10-15
08809945895328EXULT Special Instrument(CM)KZ.026.Z0122026-10-15
08809945895335EXULT Special Instrument(CM)KZ.026.Z0112026-10-15
08809945895342EXULT Special Instrument(CM)KZ.026.Z0102026-10-15
08809945895359EXULT Special Instrument(CM)KZ.026.Z0092026-10-15
08809945895366EXULT Special Instrument(CM)KZ.026.Z0082026-10-15
08809945895373EXULT Special Instrument(CM)KZ.026.Z0072026-10-15
08809945895380EXULT Special Instrument(CM)KZ.026.Z0062026-10-15
08809945895397EXULT Special Instrument(CM)KZ.026.Z0052026-10-15
08809945895403EXULT Special Instrument(CM)KZ.026.Z0042026-10-15
08800068958112BENCOX THR SystemHA.0C3.02842021-07-20
08800068946966BENCOXHA.018.28352026-07-01
08800068946973BENCOXHA.018.40622026-07-01
08800068963666BENCOXHA.018.36422026-07-01
08806373897344BENCOXHA.018.28372026-07-01
08806373897351BENCOXHA.018.32392026-07-01
08806373897368BENCOXHA.018.36442026-07-01
08806373897375BENCOXHA.018.36482026-07-01
08806373897382BENCOXHA.018.36522026-07-01
08809945870332BENCOX InstrumentHA.014.00042024-04-24

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