The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio-flex Posterior Stabilized Tibial Insert Components.
| Device ID | K041591 |
| 510k Number | K041591 |
| Device Name: | SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154020416 | K041591 | 000 |
| 07613154020218 | K041591 | 000 |
| 07613154020201 | K041591 | 000 |
| 07613154020195 | K041591 | 000 |
| 07613154020188 | K041591 | 000 |
| 07613154020171 | K041591 | 000 |
| 07613154020164 | K041591 | 000 |
| 07613154020157 | K041591 | 000 |
| 07613154020140 | K041591 | 000 |
| 07613154020133 | K041591 | 000 |
| 07613154020126 | K041591 | 000 |
| 07613154020119 | K041591 | 000 |
| 07613154020102 | K041591 | 000 |
| 07613154020096 | K041591 | 000 |
| 07613154020089 | K041591 | 000 |
| 07613154020072 | K041591 | 000 |
| 07613154020225 | K041591 | 000 |
| 07613154020232 | K041591 | 000 |
| 07613154020249 | K041591 | 000 |
| 07613154020409 | K041591 | 000 |
| 07613154020393 | K041591 | 000 |
| 07613154020386 | K041591 | 000 |
| 07613154020379 | K041591 | 000 |
| 07613154020362 | K041591 | 000 |
| 07613154020355 | K041591 | 000 |
| 07613154020331 | K041591 | 000 |
| 07613154020324 | K041591 | 000 |
| 07613154020317 | K041591 | 000 |
| 07613154020300 | K041591 | 000 |
| 07613154020294 | K041591 | 000 |
| 07613154020287 | K041591 | 000 |
| 07613154020270 | K041591 | 000 |
| 07613154020263 | K041591 | 000 |
| 07613154020256 | K041591 | 000 |
| 07613153867883 | K041591 | 000 |