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FDA 510(k)

Ascension Silicone MCP; Ascension Silicone PIP

K-Number: K233670 · 2023-12-14

ApplicantAscension Orthopedics, Inc.
Decision Date2023-12-14
Product CodeKYJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ascension Silicone MCP; Ascension Silicone PIP is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K233670. 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 Ascension Silicone MCP; Ascension Silicone PIP?

Ascension Silicone MCP; Ascension Silicone PIP is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K233670.

When did Ascension Silicone MCP; Ascension Silicone PIP receive FDA 510(k) clearance?

Ascension Silicone MCP; Ascension Silicone PIP received FDA 510(k) clearance on 2023-12-14, under 510(k) number K233670.

Who is the listed applicant for Ascension Silicone MCP; Ascension Silicone PIP?

The FDA 510(k) record lists Ascension Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ascension Silicone MCP; Ascension Silicone PIP?

The FDA product code for Ascension Silicone MCP; Ascension Silicone PIP is KYJ.

Other records listing Ascension Orthopedics, Inc. 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.

K233674Freedom Wrist Arthroplasty SystemK182878Integra Salto Total Ankle SystemK162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemK160830Integra External Fixation System

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.

K220142BRM Digitalis SpacerBrm Extremities SrlK211385KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA

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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