The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Duracon Inset Patella, 25mm.
Device ID | K993692 |
510k Number | K993692 |
Device Name: | DURACON INSET PATELLA, 25MM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Terry Sheridan Powell |
Correspondent | Terry Sheridan Powell 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 | 1999-11-02 |
Decision Date | 1999-12-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613153132738 | K993692 | 000 |