The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To Trident All Poly Cup.
Device ID | K010310 |
510k Number | K010310 |
Device Name: | MODIFICATION TO TRIDENT ALL POLY CUP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Jennifer A Daudelin |
Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-01 |
Decision Date | 2001-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327024210 | K010310 | 000 |
07613327024203 | K010310 | 000 |
07613327024180 | K010310 | 000 |
07613327024081 | K010310 | 000 |
07613327024029 | K010310 | 000 |
07613327024005 | K010310 | 000 |
07613327023923 | K010310 | 000 |