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FDA 510(k)

FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT

K-Number: K112481 · 2012-04-09

ApplicantAscension Orthopedic
Decision Date2012-04-09
Product CodeKXE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedic. It received FDA 510(k) clearance on 2012-04-09 under 510(k) number K112481. 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 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT?

FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT is a medical device that received FDA 510(k) clearance on 2012-04-09. The listed applicant is Ascension Orthopedic. The 510(k) number is K112481.

When did FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT receive FDA 510(k) clearance?

FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT received FDA 510(k) clearance on 2012-04-09, under 510(k) number K112481.

Who is the listed applicant for FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT?

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

What is the FDA product code for FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT?

The FDA product code for FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT is KXE.

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.

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Other records listing Ascension Orthopedic 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.

K131360INTEGRA TITANIUM BONE WEDGEK130050TITAN REVERSE SHOULDER SYSTEMK112438TITAN MODULAR TOTAL SHOULDER SYSTEMK112278ASCENSION NUGRIP CMC IMPLANTK111799NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

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, LLCK081025ISOELASTICURemi Sciences, Inc.K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLCK052137ASCENSION MUHAscension Orthopedics, Inc.

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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