The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Iduo Bicompartmental Knee Repair System.
| Device ID | K093513 |
| 510k Number | K093513 |
| Device Name: | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM |
| Classification | Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Contact | Amita Shah, Rac |
| Correspondent | Amita Shah, Rac CONFORMIS, INC. 2 FOURTH AVENUE Burlington, MA 01803 |
| Product Code | NPJ |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M572PAB0113508021 | K093513 | 000 |
| M572BKA1111111011 | K093513 | 000 |
| M572RBK1011112021 | K093513 | 000 |
| M572RBK0100700021 | K093513 | 000 |
| M572RBK0101000021 | K093513 | 000 |
| M572RBK0101100021 | K093513 | 000 |
| M572RBK1011113021 | K093513 | 000 |
| M572RBK0101300021 | K093513 | 000 |
| M572PAB0113206021 | K093513 | 000 |
| M572PAB0113507021 | K093513 | 000 |
| M572PAB0113808021 | K093513 | 000 |
| M572PAB0114110021 | K093513 | 000 |
| M572PAB0113207021 | K093513 | 000 |
| M572BKA1111111021 | K093513 | 000 |