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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K131409

CAS PSI KNEE SYSTEM · Orthosoft, Inc. · decided 2013-09-13 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Persona®20-8070-011-01Orthosoft IncJWH MBH OOG00889024305779
Persona®20-8070-002-01Orthosoft IncJWH MBH OOG00889024305601
Persona20-8000-010-67Orthosoft IncOLO00889024304116
Persona20-8000-010-61Orthosoft IncOLO00889024304086
Persona20-8000-010-63Orthosoft IncOLO00889024304093
Nexgen20-8070-006-01Orthosoft IncJWH MBH OOG00889024305687
Persona®20-8070-010-02Orthosoft IncJWH MBH OOG00889024305762
Persona®20-8070-010-01Orthosoft IncJWH MBH OOG00889024305755
(unnamed)20-8070-009-00Orthosoft IncJWH MBH OOG00889024305748
Persona20-8014-015-00Orthosoft IncJWH MBH OOG00889024305571
Nexgen, Legacy20-8070-004-01Orthosoft IncJWH MBH OOG00889024305649
Persona20-8000-010-65Orthosoft IncOLO00889024304109
PSI Knee803.302Orthosoft IncJWH MBH OOG00887868557606
Nexgen20-8070-008-01Orthosoft IncJWH MBH OOG00889024305724
Nexgen, Legacy20-8070-005-01Orthosoft IncJWH MBH OOG00889024305663
Persona®20-8070-001-02Orthosoft IncJWH MBH OOG00889024305595
Persona®20-8070-001-01Orthosoft IncJWH MBH OOG00889024305588
Nexgen20-8070-006-02Orthosoft IncJWH MBH OOG00889024305694
Zimmer Patient Specific Instrument803.3020Orthosoft IncJWH MBH OOG00889024211629
Nexgen, Legacy20-8070-005-02Orthosoft IncJWH MBH OOG00889024305670
Nexgen20-8070-007-01Orthosoft IncJWH MBH OOG00889024305700
Persona®20-8070-011-02Orthosoft IncJWH MBH OOG00889024305786
(unnamed)20-8014-014-00Orthosoft IncJWH MBH OOG00889024305564
Nexgen, Legacy20-8070-004-02Orthosoft IncJWH MBH OOG00889024305656
Persona®20-8070-002-02Orthosoft IncJWH MBH OOG00889024305618