Metafix Hip Stem

GUDID 05055343894026

135˚ Short Neck Trial

CORIN LTD

Femoral stem prosthesis trial
Primary Device ID05055343894026
NIH Device Record Key56b4050a-7af6-4a7f-955f-7367993659d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetafix Hip Stem
Version Model Number340.473
Company DUNS295437313
Company NameCORIN LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105055343894026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055343894026]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-19

On-Brand Devices [Metafix Hip Stem]

05055343895627ø40mm Calcar Cutter (Zimmer Drive)
05055343895610ø50mm Calcar Cutter (Zimmer Drive)
05055343895603ø45mm Calcar Cutter (Zimmer Drive)
05055343895597ø50mm Calcar Cutter (Hudson Drive)
05055343895580ø45mm Calcar Cutter (Hudson Drive)
05055343895573ø40mm Calcar Cutter (Hudson Drive)
05055343895566ø40mm Calcar Cutter (A/O Drive)
05055343895559ø45mm Calcar Cutter (A/O Drive)
05055343895542ø50mm Calcar Cutter (A/O Drive)
05055343894033125˚ Short Neck Trial
05055343894026135˚ Short Neck Trial
05055343891667Size 10 Femoral Broach
05055343891650Size 9 Femoral Broach
05055343891643Size 8 Femoral Broach
05055343891636Size 7 Femoral Broach
05055343891629Size 6 Femoral Broach
05055343891612Size 5 Femoral Broach
05055343891605Size 4 Femoral Broach
05055343891599Size 3 Femoral Broach
05055343891582Size 2 Femoral Broach
05055343891575Size 1 Femoral Broach
05055343891568Size 0 Femoral Broach
05055343891476Metafix Collared Size 9 Standard (125°)
05055343891469Metafix Collared Size 8 Standard (125°)
05055343891452Metafix Collared Size 2 Standard (125°)
05055343891445Metafix Collared Size 7 Standard (125°)
05055343891438Metafix Collared Size 6 Standard (125°)
05055343891421Metafix Collared Size 5 Standard (125°)
05055343891414Metafix Collared Size 4 Standard (125°)
05055343891407Metafix Collared Size 3 Standard (125°)
05055343891360Metafix Collared Size 2 Short Neck (125°)
05055343891339Metafix Collared Size 2 Short Neck (135°)
05055343891315Metafix Collared Size 1 Short Neck (135°)
05055343891292Metafix Collared Size 9 Standard (135°)
05055343891285Metafix Collared Size 8 Standard (135°)
05055343891278Metafix Collared Size 7 Standard (135°)
05055343891261Metafix Collared Size 6 Standard (135°)
05055343891254Metafix Collared Size 5 Standard (135°)
05055343891247Metafix Collared Size 4 Standard (135°)
05055343891230Metafix Collared Size 3 Standard (135°)
05055343891223Metafix Collared Size 2 Standard (135°)
05055343891216Metafix Collared Size 1 Standard (135°)

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