iTotal® CR Keel Punch Tip
GUDID 00850268007286
iTotal® CR 14mm Tibial Keel Punch Tip Reusable Instrument
Conformis, Inc.
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 00850268007286 |
| NIH Device Record Key | 84e4e3c4-7ed5-4f29-931a-5e9fea08c226 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTotal® CR Keel Punch Tip |
| Version Model Number | 1080-548 |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850268007286 [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 |
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
[00850268007286]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-24 |
Devices Manufactured by Conformis, Inc.
| M572TCR000D00F021 - Identity Imprint CR Knee Replacement System | 2024-07-04 CR FEMORAL INSTRUMENTS,ALL SIZES LEFT AND RIGHT |
| M572TCR000D00T021 - Identity Imprint CR Knee Replacement System | 2024-07-04 CR TIBIAL INSTRUMENTS ALL SIZES LEFT OR RIGHT |
| M572TPS000D00F021 - Identity Imprint PS Knee Replacement System | 2024-07-04 PS Femoral INSTRUMENTS,ALL SIZES LEFT AND RIGHT |
| M572TCR302T07S011 - Identity Imprint Porous CR | 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7 |
| 00810933031817 - Calcar Planer Adapter Drop-in | 2023-12-13 Calcar Planer Adapter Drop-in ED-09733 |
| M572POV0123208011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly |
| M572POV0123509011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly |
| M572POV0123809011 - Identity Imprint Porous CR | 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly |
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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