The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for 3dknee Porous Coated Femoral Component.
| Device ID | K032905 |
| 510k Number | K032905 |
| Device Name: | 3DKNEE POROUS COATED FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Kimberly L Pruitt |
| Correspondent | Kimberly L Pruitt ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2004-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912111270 | K032905 | 000 |
| 00888912111812 | K032905 | 000 |
| 00888912111805 | K032905 | 000 |
| 00888912111799 | K032905 | 000 |
| 00888912111782 | K032905 | 000 |
| 00888912111775 | K032905 | 000 |
| 00888912111768 | K032905 | 000 |
| 00888912111751 | K032905 | 000 |
| 00888912111744 | K032905 | 000 |
| 00888912111737 | K032905 | 000 |
| 00888912111720 | K032905 | 000 |
| 00888912111713 | K032905 | 000 |
| 00888912111706 | K032905 | 000 |
| 00888912111683 | K032905 | 000 |
| 00888912111676 | K032905 | 000 |
| 00888912111669 | K032905 | 000 |
| 00888912111652 | K032905 | 000 |
| 00888912111645 | K032905 | 000 |
| 00888912111836 | K032905 | 000 |
| 00888912111843 | K032905 | 000 |
| 00888912111096 | K032905 | 000 |
| 00888912111263 | K032905 | 000 |
| 00888912111256 | K032905 | 000 |
| 00888912111249 | K032905 | 000 |
| 00888912111232 | K032905 | 000 |
| 00888912111225 | K032905 | 000 |
| 00888912111218 | K032905 | 000 |
| 00888912111201 | K032905 | 000 |
| 00888912111195 | K032905 | 000 |
| 00888912111188 | K032905 | 000 |
| 00888912111171 | K032905 | 000 |
| 00888912111164 | K032905 | 000 |
| 00888912111157 | K032905 | 000 |
| 00888912111140 | K032905 | 000 |
| 00888912111133 | K032905 | 000 |
| 00888912111126 | K032905 | 000 |
| 00888912111119 | K032905 | 000 |
| 00888912111102 | K032905 | 000 |
| 00888912111638 | K032905 | 000 |