iTotal® PS Tibial Keel Punch Tip
GUDID 00850268007293
iTotal® PS 10mm Tibial Keel Punch Tip 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 | 00850268007293 |
| NIH Device Record Key | c444cfdd-46fb-4b24-a517-69be4d08dbdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTotal® PS Tibial Keel Punch Tip |
| Version Model Number | 1080-538 |
| 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
| 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 | 00850268007293 [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 |
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
Moist Heat or Steam Sterilization
[00850268007293]
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 |
On-Brand Devices [iTotal® PS Tibial Keel Punch Tip]
| 00850268007484 | iTotal® PS Tibial Keel Punch Tip Reusable Instrument |
| 00850268007477 | iTotal® PS Tibial Keel Punch Tip Reusable Instrument |
| 00850268007460 | iTotal® PS Tibial Keel Punch Tip Reusable Instrument |
| 00850268007347 | iTotal® PS 14mm Tibial Keel Punch Tip Reusable Instrument |
| 00850268007330 | iTotal® PS 12mm Tibial Keel Punch Tip Reusable Instrument |
| 00850268007323 | iTotal® PS 10mm Tibial Keel Punch Tip Reusable Instrument |
| 00850268007316 | iTotal® PS 14mm Tibial Keel Punch Tip Reusable Instrument |
| 00850268007309 | iTotal® PS 12mm Tibial Keel Punch Tip Reusable Instrument |
| 00850268007293 | iTotal® PS 10mm Tibial Keel Punch Tip 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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