PMA P040051S001

Device: STELKAST SURPASS ACETABULAR SYSTEM
Applicant: Stelkast Company
PMA number: P040051
Supplement: S001
Product code: MRA
Decision date: 2009-05-08
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement: APPROVAL FOR IMPLEMENTATION OF NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.

Current openFDA PMA Record#

Device: STELKAST SURPASS ACETABULAR SYSTEM
Applicant: Stelkast Company
PMA number: P040051
Supplement: S001
Product code: MRA
Generic name: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date: 2009-05-08
Decision code: APPR
Date received: 2007-12-17
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR IMPLEMENTATION OF NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.