FDA.reportPublic FDA data

AXIOM®

Primary DI
M684T582101
Brand
AXIOM®
Company
Microport Orthopedics Inc.
Model
T58210
Catalog number
T58210
Published
2018-08-31
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
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M684T582101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800053401142SharkCutTechcord co.,LtdGFA2024-04-15
08800053401159SharkCutTechcord co.,LtdGFA2024-04-15
08800053401166SharkCutTechcord co.,LtdGFA2024-04-15
08800053401173SharkCutTechcord co.,LtdGFA2024-04-15
08800053401180SharkCutTechcord co.,LtdGFA2024-04-15
08800053401197SharkCutTechcord co.,LtdGFA2024-04-15
08800053401203SharkCutTechcord co.,LtdGFA2024-04-15
08800053401210SharkCutTechcord co.,LtdGFA2024-04-15
08800053401227SharkCutTechcord co.,LtdGFA2024-04-15
08800053401234SharkCutTechcord co.,LtdGFA2024-04-15
08800053401241SharkCutTechcord co.,LtdGFA2024-04-15
08800053401258SharkCutTechcord co.,LtdGFA2024-04-15
08800053401289SharkCutTechcord co.,LtdGFA2024-04-15
08800053401296SharkCutTechcord co.,LtdGFA2024-04-15
08800053401302SharkCutTechcord co.,LtdGFA2024-04-15
08800053401319SharkCutTechcord co.,LtdGFA2024-04-15
08800053401326SharkCutTechcord co.,LtdGFA2024-04-15
08800053401333SharkCutTechcord co.,LtdGFA2024-04-15
08800053401265SharkCutTechcord co.,LtdGFA2024-04-12
08800053401272SharkCutTechcord co.,LtdGFA2024-04-12
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327512342CrossBladeSTRYKER CORPORATIONGFA2021-06-21
07613327512311CrossBladeSTRYKER CORPORATIONGFA2020-11-09
07613327512328CrossBladeSTRYKER CORPORATIONGFA2020-11-09
07613327512335CrossBladeSTRYKER CORPORATIONGFA2020-11-09