iTotal® Patella PAT0112906
GUDID M572PAT0112906011
N/A
Conformis, Inc.
Polyethylene patella prosthesis| Primary Device ID | M572PAT0112906011 |
| NIH Device Record Key | a73441f5-3956-4b8f-8ff0-93b084de5019 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTotal® Patella |
| Version Model Number | PAT011290601 |
| Catalog Number | PAT0112906 |
| Company DUNS | 808821883 |
| Company Name | Conformis, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
| Outer Diameter | 29 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M572PAT0112906011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142161
FDA Product Code
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-01 |
| Device Publish Date | 2020-11-23 |
On-Brand Devices [iTotal® Patella]
| M572PAT0112906011 | N/A |
| M572PAT0114110011 | N/A |
| M572PAT0113808011 | PAT011380801 |
| M572PAT0113507011 | N/A |
| M572PAT0113206011 | N/A |
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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