The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Duracon Ps Lipped Tibial Insert.
| Device ID | K012172 |
| 510k Number | K012172 |
| Device Name: | DURACON PS LIPPED TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2001-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540324153 | K012172 | 000 |
| 04546540324009 | K012172 | 000 |
| 04546540323996 | K012172 | 000 |
| 04546540323989 | K012172 | 000 |
| 04546540323972 | K012172 | 000 |
| 04546540323965 | K012172 | 000 |
| 04546540323958 | K012172 | 000 |
| 04546540323941 | K012172 | 000 |
| 04546540323934 | K012172 | 000 |
| 04546540323927 | K012172 | 000 |
| 04546540323910 | K012172 | 000 |
| 04546540323903 | K012172 | 000 |
| 04546540323897 | K012172 | 000 |
| 04546540324016 | K012172 | 000 |
| 04546540324023 | K012172 | 000 |
| 04546540324146 | K012172 | 000 |
| 04546540324139 | K012172 | 000 |
| 04546540324122 | K012172 | 000 |
| 04546540324115 | K012172 | 000 |
| 04546540324108 | K012172 | 000 |
| 04546540324092 | K012172 | 000 |
| 04546540324085 | K012172 | 000 |
| 04546540324078 | K012172 | 000 |
| 04546540324061 | K012172 | 000 |
| 04546540324054 | K012172 | 000 |
| 04546540324047 | K012172 | 000 |
| 04546540324030 | K012172 | 000 |
| 04546540323880 | K012172 | 000 |