Ascension Silicone MCP; Ascension Silicone PIP— 510(k) K233670

Name: FDA 510(k) clearance K233670
Creator: U.S. Food and Drug Administration
Published: 2023-12-14

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K233670 for Ascension Silicone MCP; Ascension Silicone PIP, Substantially Equivalent on 2023-12-14. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 2023-11-15
Decision date: 2023-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYJ

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K220142 — BRM Digitalis Spacer2023-04-04
K211385 — KeriFlex® MCP and PIP Finger Joint Prostheses2022-07-27
K140453 — OSTEOTEC SILICONE FINGER IMPLANT2015-04-17
K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER2009-02-09
K082231 — ASCENSION SILICONE PIP2009-01-12

More clearances from Ascension Orthopedics, Inc.

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K233674 — Freedom Wrist Arthroplasty System2024-05-30
K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM2013-02-13
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM2011-12-06
K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21
K100448 — ASCENSION MODULAR TOTAL SHOULDER SYSTEM2010-08-30

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.