510(k) K992144

BIOPRO RIMMED ACETABULAR COMPOMENT by Biologically Oriented Prostheses — Product Code LZO

K992144 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "BIOPRO RIMMED ACETABULAR COMPOMENT". The FDA issued a decision of Substantially Equivalent on September 22, 1999. 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. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1999
Date Received
June 24, 1999
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