The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio Total Knee System With Peri-apatite Coating.
| Device ID | K033971 |
| 510k Number | K033971 |
| Device Name: | SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Denise Duchene |
| Correspondent | Denise Duchene HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. 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 | 2003-12-22 |
| Decision Date | 2004-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327044256 | K033971 | 000 |
| 07613327044058 | K033971 | 000 |
| 07613327044041 | K033971 | 000 |
| 07613327044034 | K033971 | 000 |
| 07613327044027 | K033971 | 000 |
| 07613327044010 | K033971 | 000 |
| 07613327044003 | K033971 | 000 |
| 07613327043990 | K033971 | 000 |
| 07613327043983 | K033971 | 000 |
| 07613327043976 | K033971 | 000 |
| 07613327043969 | K033971 | 000 |
| 07613327043952 | K033971 | 000 |
| 07613327043945 | K033971 | 000 |
| 07613327043938 | K033971 | 000 |
| 07613327043921 | K033971 | 000 |
| 07613327043914 | K033971 | 000 |
| 07613327043907 | K033971 | 000 |
| 07613327043891 | K033971 | 000 |
| 07613327044065 | K033971 | 000 |
| 07613327044072 | K033971 | 000 |
| 07613327044249 | K033971 | 000 |
| 07613327044232 | K033971 | 000 |
| 07613327044225 | K033971 | 000 |
| 07613327044218 | K033971 | 000 |
| 07613327044201 | K033971 | 000 |
| 07613327044195 | K033971 | 000 |
| 07613327044188 | K033971 | 000 |
| 07613327044171 | K033971 | 000 |
| 07613327044164 | K033971 | 000 |
| 07613327044157 | K033971 | 000 |
| 07613327044140 | K033971 | 000 |
| 07613327044133 | K033971 | 000 |
| 07613327044126 | K033971 | 000 |
| 07613327044119 | K033971 | 000 |
| 07613327044102 | K033971 | 000 |
| 07613327044096 | K033971 | 000 |
| 07613327044089 | K033971 | 000 |
| 07613327043877 | K033971 | 000 |