Conformis Hip System

GUDID 00850268007880

ITOTAL HIP INSTRUMENT CASE, REAMERS

Conformis, Inc.

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID00850268007880
NIH Device Record Keyc369ef4b-4fa6-4fa3-b3f6-dc9b0e429e6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameConformis Hip System
Version Model Number1080-555
Company DUNS808821883
Company NameConformis, Inc.
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

Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850268007880 [Primary]

FDA Product Code

OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


[00850268007880]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-10-21
Device Publish Date2020-06-02

On-Brand Devices [Conformis Hip System]

M572HBS033C164011STEM, COLLARED, HIP, SIZE 16, 132 DEG, 36.5 MM
M572HBS033C163011STEM, COLLARED, HIP, SIZE 16, 127 DEG, 36.5 MM
M572HBS033C154011STEM, COLLARED, HIP, SIZE 15, 132 DEG, 36.5 MM
M572HBS033C153011STEM, COLLARED, HIP, SIZE 15, 127 DEG, 36.5 MM
M572HBS033C144011STEM, COLLARED, HIP, SIZE 14, 132 DEG, 36.5 MM
M572HBS033C143011STEM, COLLARED, HIP, SIZE 14, 127 DEG, 36.5 MM
M572HBS033C134011STEM, COLLARED, HIP, SIZE 13, 132 DEG, 36.5 MM
M572HBS033C133011STEM, COLLARED, HIP, SIZE 13, 127 DEG, 36.5 MM
M572HBS033C132011STEM, COLLARED, HIP, SIZE 13, 132 DEG, 29.0 MM
M572HBS033C131011STEM, COLLARED, HIP, SIZE 13, 127 DEG, 29.0 MM
M572HBS033C124011STEM, COLLARED, HIP, SIZE 12, 132 DEG, 36.5 MM
M572HBS033C123011STEM, COLLARED, HIP, SIZE 12, 127 DEG, 36.5 MM
M572HBS033C122011STEM, COLLARED, HIP, SIZE 12, 132 DEG, 29.0 MM
M572HBS033C121011STEM, COLLARED, HIP, SIZE 12, 127 DEG, 29.0 MM
M572HBS033C114011STEM, COLLARED, HIP, SIZE 11, 132 DEG, 36.5 MM
M572HBS033C113011STEM, COLLARED, HIP, SIZE 11, 127 DEG, 36.5 MM
M572HBS033C112011STEM, COLLARED, HIP, SIZE 11, 132 DEG, 29.0 MM
M572HBS033C111011STEM, COLLARED, HIP, SIZE 11, 127 DEG, 29.0 MM
M572HBS033C104011STEM, COLLARED, HIP, SIZE 10, 132 DEG, 36.5 MM
M572HBS033C103011STEM, COLLARED, HIP, SIZE 10, 127 DEG, 36.5 MM
M572HBS033C102011STEM, COLLARED, HIP, SIZE 10, 132 DEG, 29.0 MM
M572HBS033C101011STEM, COLLARED, HIP, SIZE 10, 127 DEG, 29.0 MM
M572HCC032B065011ACETABULAR CUP, PLASMA SPRAY 65
M572HCC032B064011ACETABULAR CUP, PLASMA SPRAY 64
M572HCC032B063011ACETABULAR CUP, PLASMA SPRAY 63
M572HCC032B062011ACETABULAR CUP, PLASMA SPRAY 62
M572HCC032B061011ACETABULAR CUP, PLASMA SPRAY 61
M572HCC032B060011ACETABULAR CUP, PLASMA SPRAY 60
M572HCC032B059011ACETABULAR CUP, PLASMA SPRAY 59
M572HCC032B058011ACETABULAR CUP, PLASMA SPRAY 58
M572HCC032B057011ACETABULAR CUP, PLASMA SPRAY 57
M572HCC032B056011ACETABULAR CUP, PLASMA SPRAY 56
M572HCC032B055011ACETABULAR CUP, PLASMA SPRAY 55
M572HCC032B054011ACETABULAR CUP, PLASMA SPRAY 54
M572HCC032B053011ACETABULAR CUP, PLASMA SPRAY 53
M572HCC032B052011ACETABULAR CUP, PLASMA SPRAY 52
M572HCC032B051011ACETABULAR CUP, PLASMA SPRAY 51
M572HCC032B050011ACETABULAR CUP, PLASMA SPRAY 50
M572HCC032B049011ACETABULAR CUP, PLASMA SPRAY 49
M572HCC032B048011ACETABULAR CUP, PLASMA SPRAY 48
M572HCC032B047011ACETABULAR CUP, PLASMA SPRAY 47
M572HCC032B046011ACETABULAR CUP, PLASMA SPRAY 46
M572HBS033C162011STEM, COLLARED, HIP, SIZE 16, 132 DEG, 29.0 MM
M572HBS033C161011STEM, COLLARED, HIP, SIZE 16, 127 DEG, 29.0 MM
M572HBS033C152011STEM, COLLARED, HIP, SIZE 15, 132 DEG, 29.0 MM
M572HBS033C151011STEM, COLLARED, HIP, SIZE 15, 127 DEG, 29.0 MM
M572HBS033C142011STEM, COLLARED, HIP, SIZE 14, 132 DEG, 29.0 MM
M572HBS033C141011STEM, COLLARED, HIP, SIZE 14, 127 DEG, 29.0 MM
M572HCC032B066011ACETABULAR CUP, PLASMA SPRAY 66
M572HAR000S244011HIP-REAMER STAGE 2-44MM

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