iDuo® Patella PAB0113507
GUDID M572PAB0113507021
N/A
Conformis, Inc.
Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis 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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