iTotal® Patella Sizer
GUDID 00850268007156
iTotal® 35mm Patella Sizer Reusable Instrument
Conformis, Inc.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00850268007156 |
| NIH Device Record Key | b781bbf8-39da-4b04-85c3-7e9173cbb267 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTotal® Patella Sizer |
| Version Model Number | 1080-530 |
| 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 |
Customer Support Contacts
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com | |
| Phone | 781-345-9001 |
| customer-service@conformis.com |
Device Dimensions
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
| Outer Diameter | 35 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850268007156 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160025
FDA Product Code
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
[00850268007156]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2016-10-24 |
On-Brand Devices [iTotal® Patella Sizer]
| 00850268007170 | iTotal® 41mm Patella Sizer Reusable Instrument |
| 00850268007163 | iTotal® 38mm Patella Sizer Reusable Instrument |
| 00850268007156 | iTotal® 35mm Patella Sizer Reusable Instrument |
| 00850268007149 | iTotal® 32mm Patella Sizer Reusable Instrument |
| 00850268007132 | iTotal® 29mm Patella Sizer Reusable Instrument |
Trademark Results [iTotal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ITOTAL 79337466 not registered Live/Pending |
TOTAL JUGGLING S.r.l 2021-10-06 |
 ITOTAL 77519937 4006512 Live/Registered |
ConforMIS, Inc. 2008-07-11 |
 ITOTAL 77200561 not registered Dead/Abandoned |
ConforMIS, Inc. 2007-06-07 |
 ITOTAL 76133213 2498210 Dead/Cancelled |
ConnecTotal Staffing, Inc. 2000-09-22 |
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