510(k) K973307

S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD by Johnson & Johnson Professionals, Inc. — Product Code LZO

Clearance Details

Decision
SN ()
Decision Date
November 20, 1997
Date Received
September 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type