Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971581
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
More FDA Info for this Device
510(K) Number
K971581
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER, UT 84020 US
Other 510(k) Applications for this Company
Contact
CAROL FREASIER
Other 510(k) Applications for this Contact
Regulation Number
888.3350
More FDA Info for this Regulation Number
Classification Product Code
JDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/1997
Decision Date
07/18/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact