The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Abc Total Elbow Prothesis.
Device ID | K972691 |
510k Number | K972691 |
Device Name: | ABC TOTAL ELBOW PROTHESIS |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Karl Schwartz |
Correspondent | Karl Schwartz BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-17 |
Decision Date | 1997-10-15 |
Summary: | summary |