FDA 510(k) Applications for Medical Device Product Code "KYJ"
(Prosthesis, Finger, Constrained, Polymer)

FDA 510(k) Number Applicant Device Name Decision Date
K082231 ASCENSION ORTHOPEDICS, INC. ASCENSION SILICONE PIP 01/12/2009
K022892 ASCENSION ORTHOPEDICS, INC. ASCENSION SILLICONE MCP 11/25/2002
K013629 AVANTA ORTHOPAEDICS, INC. FINGER JOINT PROSTHESIS 01/25/2002
K220142 BRM Extremities Srl BRM Digitalis Spacer 04/04/2023
K083107 DEPUY ORTHOPAEDICS, INC. MODIFICATION TO DEPUY NEUFLEX PIP FINGER 02/09/2009
K970544 DEPUY, INC. DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS 09/12/1997
K001922 DEPUY, INC. DEPUY NEUFLEX PIP FINGER 08/29/2000
K211385 Keri Medical SA KeriFlex« MCP and PIP Finger Joint Prostheses 07/27/2022
K140453 OSTEOTEC LTD OSTEOTEC SILICONE FINGER IMPLANT 04/17/2015


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact