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510(k) K211385

KeriFlex® MCP and PIP Finger Joint Prostheses by Keri Medical SA — Product Code KYJ

K211385 is an FDA 510(k) premarket notification submitted by Keri Medical SA for the device "KeriFlex® MCP and PIP Finger Joint Prostheses". The FDA issued a decision of Substantially Equivalent on July 27, 2022. The device falls under product code KYJ (Prosthesis, Finger, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3230.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2022
Date Received
May 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Finger, Constrained, Polymer
Device Class
Class II
Regulation Number
888.3230
Review Panel
OR
Submission Type

Other clearances for product code KYJ

  • K233670 — Ascension Silicone MCP; Ascension Silicone PIP (December 14, 2023)
  • K220142 — BRM Digitalis Spacer (April 4, 2023)
  • K140453 — OSTEOTEC SILICONE FINGER IMPLANT (April 17, 2015)
  • K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER (February 9, 2009)
  • K082231 — ASCENSION SILICONE PIP (January 12, 2009)
  • K022892 — ASCENSION SILLICONE MCP (November 25, 2002)
  • K013629 — FINGER JOINT PROSTHESIS (January 25, 2002)
  • K001922 — DEPUY NEUFLEX PIP FINGER (August 29, 2000)
  • K970544 — DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (September 12, 1997)
  • K931588 — SUTTER PROXIMAL INTERPHALANGEAL JOINT (March 10, 1994)

FDA data resources