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FDA 510(k)

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

K-Number: K102549 · 2010-12-21

ApplicantAscension Orthopedics, Inc.
Decision Date2010-12-21
Product CodeLZJ
DecisionSubstantially Equivalent

Device Summary

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY 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 2010-12-21 under 510(k) number K102549. The device is classified under product code LZJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY?

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K102549.

When did THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY receive FDA 510(k) clearance?

THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102549.

Who is the listed applicant for THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY?

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 THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY?

The FDA product code for THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY is LZJ.

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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 SYSTEMK100448ASCENSION MODULAR TOTAL SHOULDER SYSTEMK100502ASCENSION TOTAL PLATE SYSTEM

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Related Devices (Code: LZJ)

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.

K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMerete Medical GmbHK950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)Acu Med, Inc.K941650TOTAL TOE SYSTEM IIBiomet, Inc.K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.K922211OSTEOMED GREAT TOE SYSTEMOsteomed Corp.K920446TOTAL TOE SYSTEMBiomet, 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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