iDuo® Patella PAB0113507
GUDID M572PAB0113507021
N/A
Conformis, Inc.
Polyethylene patella prosthesis| Primary Device ID | M572PAB0113507021 |
| NIH Device Record Key | def00308-3da2-4a25-9ee7-ca199f115bc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iDuo® Patella |
| Version Model Number | PAB011350702 |
| Catalog Number | PAB0113507 |
| 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 | 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 |
| 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 |
|---|---|
| HIBCC | M572PAB0113507021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093513
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2015-10-26 |
On-Brand Devices [iDuo® Patella]
| M572PAB0113508021 | PAB011350802 |
| M572PAB0113207021 | PAB011320702 |
| M572PAB0114110021 | N/A |
| M572PAB0113808021 | N/A |
| M572PAB0113507021 | N/A |
| M572PAB0113206021 | N/A |
Trademark Results [iDuo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IDUO 85794905 not registered Dead/Abandoned |
i do it sarl 2012-12-05 |
 IDUO 85518103 4270942 Live/Registered |
Liang, Hsien-Rong 2012-01-17 |
 IDUO 78652189 not registered Dead/Abandoned |
Liang, Hsien-Rong 2005-06-16 |
 IDUO 77200574 3459154 Dead/Cancelled |
ConforMIS, Inc. 2007-06-07 |
 IDUO 77087559 not registered Dead/Abandoned |
I DO IT SPRLU 2007-01-22 |
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