STERIZO Total Hip System M-1200-0046-01

GUDID B565M12000046011

Apical Hole Plug

CPM MEDICAL CONSULTANTS, LLC

Coated femoral stem prosthesis, modular
Primary Device IDB565M12000046011
NIH Device Record Keydf7dc3bb-0626-46de-8da3-06ce15616d23
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERIZO Total Hip System
Version Model NumberRev A
Catalog NumberM-1200-0046-01
Company DUNS017138000
Company NameCPM MEDICAL CONSULTANTS, LLC
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

Customer Support Contacts

Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB565M12000046011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


[B565M12000046011]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-23
Device Publish Date2022-02-15

On-Brand Devices [STERIZO Total Hip System]

B565M110013751Taper Stem, Std Offset Sz 13.75
B565M110012501Taper Stem, Std Offset Sz 12.5
B565M110011251Taper Stem, Std Offset Sz 11.25
B565M110010001Taper Stem, Std Offset Sz 10.0
B565M110008751Taper Stem, Std Offset Sz 8.75
B565M110007501Taper Stem, Std Offset Sz 7.5
B565M110006001Taper Stem, Std Offset Sz 6.0
B565M221550321Liner, Elevated Face Sz 50x32
B565M150040011Dome Impactor Sz 40
B565M150036011Dome Impactor Sz 36
B565M150032011Dome Impactor Sz 32
B565M150028011Dome Impactor Sz 28
B565M150010181Bi-Polar Trial Handle
B565M150010171Calcar Planar
B565M150010161Cup Alignment Guide
B565M150010151Shell Impactor Spacer
B565M150010141Handle, Straight Reamer
B565M110017751Taper Stem, Std Offset Sz 17.75
B565M110015001Taper Stem, Std Offset Sz 15.0
B565M221552321Liner, Elevated Face Sz 52x32
B565MEBS65451Bone Screw, 6.5mm X 45mm
B565MEBS65401Bone Screw, 6.5mm X 40mm
B565MEBS65351Bone Screw, 6.5mm X 35mm
B565MEBS65301Bone Screw, 6.5mm X 30mm
B565MEBS65251Bone Screw, 6.5mm X 25mm
B565MEBS65201Bone Screw, 6.5mm X 20mm
B565MEBS65151Bone Screw, 6.5mm X 15mm
B565M221566401Liner, Elevated Face Sz 66x40
B565M221566321Liner, Elevated Face Sz 66x32
B565M221566281Liner, Elevated Face Sz 66x28
B565M221562401Liner, Elevated Face Sz 62x40
B565M221562321Liner, Elevated Face Sz 62x32
B565M221562281Liner, Elevated Face Sz 62x28
B565M221558401Liner, Elevated Face Sz 58x40
B565M221558321Liner, Elevated Face Sz 58x32
B565M221558281Liner, Elevated Face Sz 58x28
B565M221554361Liner, Elevated Face Sz 54x36
B565M221554321Liner, Elevated Face Sz 54x32
B565M221554281Liner, Elevated Face Sz 54x28
B565M221552361Liner, Elevated Face Sz 52x36
B565M221552281Liner, Elevated Face Sz 52x28
B565M221550281Liner, Elevated Face Sz 50x28
B565M221546281Liner, Elevated Face Sz 46x28
B565M220066401Liner, Neutral Face Sz 66x40
B565M220066321Liner, Neutral Face Sz 66x32
B565M220066281Liner, Neutral Face Sz 66x28
B565M220062401Liner, Neutral Face Sz 62x40
B565M220062321Liner, Neutral Face Sz 62x32
B565M220062281Liner, Neutral Face Sz 62x28
B565M220058401Liner, Neutral Face Sz 58x40

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.