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FDA 510(k)

KeriFlex® MCP and PIP Finger Joint Prostheses

K-Number: K211385 · 2022-07-27

ApplicantKeri Medical SA
Decision Date2022-07-27
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeriFlex® MCP and PIP Finger Joint Prostheses is the device name listed in this FDA 510(k) record. The listed applicant is Keri Medical SA. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K211385. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeriFlex® MCP and PIP Finger Joint Prostheses?

KeriFlex® MCP and PIP Finger Joint Prostheses is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Keri Medical SA. The 510(k) number is K211385.

When did KeriFlex® MCP and PIP Finger Joint Prostheses receive FDA 510(k) clearance?

KeriFlex® MCP and PIP Finger Joint Prostheses received FDA 510(k) clearance on 2022-07-27, under 510(k) number K211385.

Who is the listed applicant for KeriFlex® MCP and PIP Finger Joint Prostheses?

The FDA 510(k) record lists Keri Medical SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses?

The FDA product code for KeriFlex® MCP and PIP Finger Joint Prostheses is KYJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06546332Post Market Clinical Follow-Up KeriFuse®ACTIVE_NOT_RECRUITINGNCT07405983TOUCH® CMC 1 New Enrollment US StudyRECRUITINGNCT02244788Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal JointAVAILABLENCT07714356Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.NOT_YET_RECRUITING

Other records listing Keri Medical SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240020Prosthesis, finger, semi-constrained, metal/polymer

Related Devices (Code: KYJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc.K220142BRM Digitalis SpacerBrm Extremities Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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