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FDA 510(k)

ASCENSION MUH

K-Number: K052137 · 2005-11-03

ApplicantAscension Orthopedics, Inc.
Decision Date2005-11-03
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION MUH 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 2005-11-03 under 510(k) number K052137. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENSION MUH?

ASCENSION MUH is a medical device that received FDA 510(k) clearance on 2005-11-03. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K052137.

When did ASCENSION MUH receive FDA 510(k) clearance?

ASCENSION MUH received FDA 510(k) clearance on 2005-11-03, under 510(k) number K052137.

Who is the listed applicant for ASCENSION MUH?

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 MUH?

The FDA product code for ASCENSION MUH is KXE.

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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 SystemK233670Ascension Silicone MCP; Ascension Silicone PIPK121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEMK110700ASCENSION ATLAS HUMERAL PLATING SYSTEMK102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYK100448ASCENSION MODULAR TOTAL SHOULDER SYSTEM

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Related Devices (Code: KXE)

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.

K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLCK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension OrthopedicK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC

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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