The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Cordera Hip System.
| Device ID | K202484 |
| 510k Number | K202484 |
| Device Name: | Cordera Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810933031213 | K202484 | 000 |
| M572HDA050C22S011 | K202484 | 000 |
| M572HDA050D22S011 | K202484 | 000 |
| M572HDA050D32S011 | K202484 | 000 |
| M572HDA050E22S011 | K202484 | 000 |
| M572HDA050E32S011 | K202484 | 000 |
| M572HDA050F22S011 | K202484 | 000 |
| M572HDA050F32S011 | K202484 | 000 |
| 00810933031145 | K202484 | 000 |
| 00810933031152 | K202484 | 000 |
| 00810933031169 | K202484 | 000 |
| 00810933031176 | K202484 | 000 |
| 00810933031183 | K202484 | 000 |
| 00810933031190 | K202484 | 000 |
| 00810933031206 | K202484 | 000 |
| M572HDA050B12S011 | K202484 | 000 |