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 a medical device manufactured by Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-12-14 under approval 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. It is manufactured by Ascension Orthopedics, Inc.. The 510(k) number is K233670.
When was Ascension Silicone MCP; Ascension Silicone PIP approved by the FDA?
Ascension Silicone MCP; Ascension Silicone PIP received FDA 510(k) clearance on 2023-12-14, under approval number K233670.
What company makes Ascension Silicone MCP; Ascension Silicone PIP?
Ascension Silicone MCP; Ascension Silicone PIP is manufactured by Ascension Orthopedics, Inc..
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 Devices by Ascension Orthopedics, Inc.
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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.