510(k) K921111

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD by Joint Medical Products Corp. — Product Code LZO

K921111 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on October 22, 1992. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1992
Date Received
March 9, 1992
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