The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon Total Knee System.
| Device ID | K032163 |
| 510k Number | K032163 |
| Device Name: | DURACON TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-15 |
| Decision Date | 2003-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540318343 | K032163 | 000 |
| 04546540318176 | K032163 | 000 |
| 04546540318169 | K032163 | 000 |
| 04546540318152 | K032163 | 000 |
| 04546540318145 | K032163 | 000 |
| 04546540318138 | K032163 | 000 |
| 04546540318121 | K032163 | 000 |
| 04546540318114 | K032163 | 000 |
| 04546540318107 | K032163 | 000 |
| 04546540318091 | K032163 | 000 |
| 04546540318084 | K032163 | 000 |
| 04546540318077 | K032163 | 000 |
| 04546540318060 | K032163 | 000 |
| 04546540318053 | K032163 | 000 |
| 04546540318046 | K032163 | 000 |
| 04546540318183 | K032163 | 000 |
| 04546540318190 | K032163 | 000 |
| 04546540318336 | K032163 | 000 |
| 04546540318329 | K032163 | 000 |
| 04546540318312 | K032163 | 000 |
| 04546540318305 | K032163 | 000 |
| 04546540318299 | K032163 | 000 |
| 04546540318282 | K032163 | 000 |
| 04546540318275 | K032163 | 000 |
| 04546540318268 | K032163 | 000 |
| 04546540318251 | K032163 | 000 |
| 04546540318244 | K032163 | 000 |
| 04546540318237 | K032163 | 000 |
| 04546540318220 | K032163 | 000 |
| 04546540318213 | K032163 | 000 |
| 04546540318206 | K032163 | 000 |
| 04546540318039 | K032163 | 000 |