The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon X3 Cs Tibial Insert.
| Device ID | K070883 |
| 510k Number | K070883 |
| Device Name: | DURACON X3 CS TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327141283 | K070883 | 000 |
| 07613327048926 | K070883 | 000 |
| 07613327048902 | K070883 | 000 |