Primary Device ID | 00850268007880 |
NIH Device Record Key | c369ef4b-4fa6-4fa3-b3f6-dc9b0e429e6c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Conformis Hip System |
Version Model Number | 1080-555 |
Company DUNS | 808821883 |
Company Name | Conformis, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850268007880 [Primary] |
OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[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
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-10-21 |
Device Publish Date | 2020-06-02 |
M572HBS033C164011 | STEM, COLLARED, HIP, SIZE 16, 132 DEG, 36.5 MM |
M572HBS033C163011 | STEM, COLLARED, HIP, SIZE 16, 127 DEG, 36.5 MM |
M572HBS033C154011 | STEM, COLLARED, HIP, SIZE 15, 132 DEG, 36.5 MM |
M572HBS033C153011 | STEM, COLLARED, HIP, SIZE 15, 127 DEG, 36.5 MM |
M572HBS033C144011 | STEM, COLLARED, HIP, SIZE 14, 132 DEG, 36.5 MM |
M572HBS033C143011 | STEM, COLLARED, HIP, SIZE 14, 127 DEG, 36.5 MM |
M572HBS033C134011 | STEM, COLLARED, HIP, SIZE 13, 132 DEG, 36.5 MM |
M572HBS033C133011 | STEM, COLLARED, HIP, SIZE 13, 127 DEG, 36.5 MM |
M572HBS033C132011 | STEM, COLLARED, HIP, SIZE 13, 132 DEG, 29.0 MM |
M572HBS033C131011 | STEM, COLLARED, HIP, SIZE 13, 127 DEG, 29.0 MM |
M572HBS033C124011 | STEM, COLLARED, HIP, SIZE 12, 132 DEG, 36.5 MM |
M572HBS033C123011 | STEM, COLLARED, HIP, SIZE 12, 127 DEG, 36.5 MM |
M572HBS033C122011 | STEM, COLLARED, HIP, SIZE 12, 132 DEG, 29.0 MM |
M572HBS033C121011 | STEM, COLLARED, HIP, SIZE 12, 127 DEG, 29.0 MM |
M572HBS033C114011 | STEM, COLLARED, HIP, SIZE 11, 132 DEG, 36.5 MM |
M572HBS033C113011 | STEM, COLLARED, HIP, SIZE 11, 127 DEG, 36.5 MM |
M572HBS033C112011 | STEM, COLLARED, HIP, SIZE 11, 132 DEG, 29.0 MM |
M572HBS033C111011 | STEM, COLLARED, HIP, SIZE 11, 127 DEG, 29.0 MM |
M572HBS033C104011 | STEM, COLLARED, HIP, SIZE 10, 132 DEG, 36.5 MM |
M572HBS033C103011 | STEM, COLLARED, HIP, SIZE 10, 127 DEG, 36.5 MM |
M572HBS033C102011 | STEM, COLLARED, HIP, SIZE 10, 132 DEG, 29.0 MM |
M572HBS033C101011 | STEM, COLLARED, HIP, SIZE 10, 127 DEG, 29.0 MM |
M572HCC032B065011 | ACETABULAR CUP, PLASMA SPRAY 65 |
M572HCC032B064011 | ACETABULAR CUP, PLASMA SPRAY 64 |
M572HCC032B063011 | ACETABULAR CUP, PLASMA SPRAY 63 |
M572HCC032B062011 | ACETABULAR CUP, PLASMA SPRAY 62 |
M572HCC032B061011 | ACETABULAR CUP, PLASMA SPRAY 61 |
M572HCC032B060011 | ACETABULAR CUP, PLASMA SPRAY 60 |
M572HCC032B059011 | ACETABULAR CUP, PLASMA SPRAY 59 |
M572HCC032B058011 | ACETABULAR CUP, PLASMA SPRAY 58 |
M572HCC032B057011 | ACETABULAR CUP, PLASMA SPRAY 57 |
M572HCC032B056011 | ACETABULAR CUP, PLASMA SPRAY 56 |
M572HCC032B055011 | ACETABULAR CUP, PLASMA SPRAY 55 |
M572HCC032B054011 | ACETABULAR CUP, PLASMA SPRAY 54 |
M572HCC032B053011 | ACETABULAR CUP, PLASMA SPRAY 53 |
M572HCC032B052011 | ACETABULAR CUP, PLASMA SPRAY 52 |
M572HCC032B051011 | ACETABULAR CUP, PLASMA SPRAY 51 |
M572HCC032B050011 | ACETABULAR CUP, PLASMA SPRAY 50 |
M572HCC032B049011 | ACETABULAR CUP, PLASMA SPRAY 49 |
M572HCC032B048011 | ACETABULAR CUP, PLASMA SPRAY 48 |
M572HCC032B047011 | ACETABULAR CUP, PLASMA SPRAY 47 |
M572HCC032B046011 | ACETABULAR CUP, PLASMA SPRAY 46 |
M572HBS033C162011 | STEM, COLLARED, HIP, SIZE 16, 132 DEG, 29.0 MM |
M572HBS033C161011 | STEM, COLLARED, HIP, SIZE 16, 127 DEG, 29.0 MM |
M572HBS033C152011 | STEM, COLLARED, HIP, SIZE 15, 132 DEG, 29.0 MM |
M572HBS033C151011 | STEM, COLLARED, HIP, SIZE 15, 127 DEG, 29.0 MM |
M572HBS033C142011 | STEM, COLLARED, HIP, SIZE 14, 132 DEG, 29.0 MM |
M572HBS033C141011 | STEM, COLLARED, HIP, SIZE 14, 127 DEG, 29.0 MM |
M572HCC032B066011 | ACETABULAR CUP, PLASMA SPRAY 66 |
M572HAR000S244011 | HIP-REAMER STAGE 2-44MM |