Iconacy i-Hip 01-10104-056-00

GUDID M914011010405600

ACETABULAR CUP, 2-HOLE, 56MM O.D.

Iconacy Orthopedic Implants LLC

Acetabular shell
Primary Device IDM914011010405600
NIH Device Record Keyac09e87b-9d04-4c2e-9435-cf8b0ae663ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameIconacy i-Hip
Version Model Number01-10104-056-00
Catalog Number01-10104-056-00
Company DUNS032218374
Company NameIconacy Orthopedic Implants LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com
Phone574-269-4266
Emailrhori@iconacy.com

Device Dimensions

Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter
Outer Diameter56 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM914011010405600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-09
Device Publish Date2015-11-06

On-Brand Devices [Iconacy i-Hip]

M914011020301201FEMORAL HEAD, 36MM DIAMETER, +12MM NECK
M914011020300801FEMORAL HEAD, 36MM DIAMETER, +8MM NECK
M914011020300401FEMORAL HEAD, 36MM DIAMETER, +4MM NECK
M914011020300201FEMORAL HEAD, 36MM DIAMETER, +0MM NECK
M914011020300001FEMORAL HEAD, 36MM DIAMETER, -4MM NECK
M914011020201201FEMORAL HEAD, 32MM DIAMETER, +12MM NECK
M914011020200801FEMORAL HEAD, 32MM DIAMETER, +8MM NECK
M914011020200401FEMORAL HEAD, 32MM DIAMETER, +4MM NECK
M914011020200201FEMORAL HEAD, 32MM DIAMETER, +0MM NECK
M914011020200001FEMORAL HEAD, 32MM DIAMETER, -4MM NECK
M914011020101201FEMORAL HEAD, 28MM DIAMETER, +12MM NECK
M914011020100801FEMORAL HEAD, 28MM DIAMETER, +8MM NECK
M914011020100401FEMORAL HEAD, 28MM DIAMETER, +4MM NECK
M914011020100201FEMORAL HEAD, 28MM DIAMETER, +0MM NECK
M914011020100001FEMORAL HEAD, 28MM DIAMETER, -4MM NECK
M914011010406400ACETABULAR CUP, 2-HOLE, 64MM O.D.
M914011010406200ACETABULAR CUP, 2-HOLE, 62MM O.D.
M914011010406000ACETABULAR CUP, 2-HOLE, 60MM O.D.
M914011010405800ACETABULAR CUP, 2-HOLE, 58MM O.D.
M914011010405600ACETABULAR CUP, 2-HOLE, 56MM O.D.
M914011010405400ACETABULAR CUP, 2-HOLE, 54MM O.D.
M914011010405200ACETABULAR CUP, 2-HOLE, 52MM O.D.
M914011010405000ACETABULAR CUP, 2-HOLE, 50MM O.D.
M914011010404800ACETABULAR CUP, 2-HOLE, 48MM O.D.
M914011010404600ACETABULAR CUP, 2-HOLE, 46MM O.D.
M914011010306400RS ACETABULAR CUP, FINNED, 2-HOLE, 64MM O.D.
M914011010306200RS ACETABULAR CUP, FINNED, 2-HOLE, 62MM O.D.
M914011010306000RS ACETABULAR CUP, FINNED, 2-HOLE, 60MM O.D.
M914011010305800RS ACETABULAR CUP, FINNED, 2-HOLE, 58MM O.D.
M914011010305600RS ACETABULAR CUP, FINNED, 2-HOLE, 56MM O.D.
M914011010305400RS ACETABULAR CUP, FINNED, 2-HOLE, 54MM O.D.
M914011010305200RS ACETABULAR CUP, FINNED, 2-HOLE, 52MM O.D.
M914011010305000RS ACETABULAR CUP, FINNED, 2-HOLE, 50MM O.D.
M914011010304800RS ACETABULAR CUP, FINNED, 2-HOLE, 48MM O.D.
M914011010304600RS ACETABULAR CUP, FINNED, 2-HOLE, 46MM O.D.
M914011010206400RS ACETABULAR CUP, SPIKED, 64MM O.D.
M914011010206200RS ACETABULAR CUP, SPIKED, 62MM O.D.
M914011010206000RS ACETABULAR CUP, SPIKED, 60MM O.D.
M914011010205800RS ACETABULAR CUP, SPIKED, 58MM O.D.
M914011010205600RS ACETABULAR CUP, SPIKED, 56MM O.D.
M914011010205400RS ACETABULAR CUP, SPIKED, 54MM O.D.
M914011010205200RS ACETABULAR CUP, SPIKED, 52MM O.D.
M914011010205000RS ACETABULAR CUP, SPIKED, 50MM O.D.
M914011010204800RS ACETABULAR CUP, SPIKED, 48MM O.D.
M914011010204600RS ACETABULAR CUP, SPIKED, 46MM O.D.
M914011010106400RS ACETABULAR CUP, 2-HOLE, 64MM O.D.
M914011010106200RS ACETABULAR CUP, 2-HOLE, 62MM O.D.
M914011010106000RS ACETABULAR CUP, 2-HOLE, 60MM O.D.
M914011010105600RS ACETABULAR CUP, 2-HOLE, 56MM O.D.
M914011010105400RS ACETABULAR CUP, 2-HOLE, 54MM O.D.
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.