KeriFlex® MCP and PIP Finger Joint Prostheses— 510(k) K211385

Name: FDA 510(k) clearance K211385
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Substantially Equivalent

Keri Medical SA

FDA 510(k) clearance K211385 for KeriFlex® MCP and PIP Finger Joint Prostheses, Substantially Equivalent on 2022-07-27. Applicant: Keri Medical SA. Device class: 2.

Clearance details

Applicant: Keri Medical SA
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 2021-05-04
Decision date: 2022-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYJ

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K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
K220142 — BRM Digitalis Spacer2023-04-04
K140453 — OSTEOTEC SILICONE FINGER IMPLANT2015-04-17
K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER2009-02-09
K082231 — ASCENSION SILICONE PIP2009-01-12

Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.