The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Patriot Protrusio Cage.
Device ID | K020076 |
510k Number | K020076 |
Device Name: | PATRIOT PROTRUSIO CAGE |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Tracy J Bickel |
Correspondent | Tracy J Bickel BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-09 |
Decision Date | 2002-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304465459 | K020076 | 000 |
00880304225466 | K020076 | 000 |
00880304225473 | K020076 | 000 |
00880304462526 | K020076 | 000 |
00880304464452 | K020076 | 000 |
00880304464469 | K020076 | 000 |
00880304464476 | K020076 | 000 |
00880304464483 | K020076 | 000 |
00880304464490 | K020076 | 000 |
00880304464506 | K020076 | 000 |
00880304464513 | K020076 | 000 |
00880304464520 | K020076 | 000 |
00880304464537 | K020076 | 000 |
00880304464681 | K020076 | 000 |
00880304225268 | K020076 | 000 |