The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Unicondylar Knee.
| Device ID | K020741 |
| 510k Number | K020741 |
| Device Name: | UNICONDYLAR KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912116169 | K020741 | 000 |
| 00888912108980 | K020741 | 000 |
| 00888912108973 | K020741 | 000 |
| 00888912108966 | K020741 | 000 |
| 00888912108942 | K020741 | 000 |
| 00888912108935 | K020741 | 000 |
| 00888912108928 | K020741 | 000 |
| 00888912108904 | K020741 | 000 |
| 00888912108898 | K020741 | 000 |
| 00888912116046 | K020741 | 000 |
| 00888912115889 | K020741 | 000 |
| 00888912115902 | K020741 | 000 |
| 00888912115919 | K020741 | 000 |
| 00888912116152 | K020741 | 000 |
| 00888912116145 | K020741 | 000 |
| 00888912116107 | K020741 | 000 |
| 00888912116091 | K020741 | 000 |
| 00888912116084 | K020741 | 000 |
| 00888912116039 | K020741 | 000 |
| 00888912116022 | K020741 | 000 |
| 00888912115988 | K020741 | 000 |
| 00888912115971 | K020741 | 000 |
| 00888912115957 | K020741 | 000 |