The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Scorpio Total Knee Relaxed Back P/s Tibial Bearing Insert.
| Device ID | K991461 |
| 510k Number | K991461 |
| Device Name: | OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-27 |
| Decision Date | 1999-05-17 |
| Summary: | summary |