Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K972691
Device Classification Name
Prosthesis, Elbow, Semi-Constrained, Cemented
More FDA Info for this Device
510(K) Number
K972691
Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
KARL SCHWARTZ
Other 510(k) Applications for this Contact
Regulation Number
888.3160
More FDA Info for this Regulation Number
Classification Product Code
JDB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/1997
Decision Date
10/15/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact