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FDA 510(k)

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

K-Number: K111799 · 2011-08-19

ApplicantAscension Orthopedic
Decision Date2011-08-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedic. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111799. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUGAIT(TM) SUBTALAR IMPLANT SYSTEM?

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Ascension Orthopedic. The 510(k) number is K111799.

When did NUGAIT(TM) SUBTALAR IMPLANT SYSTEM receive FDA 510(k) clearance?

NUGAIT(TM) SUBTALAR IMPLANT SYSTEM received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111799.

Who is the listed applicant for NUGAIT(TM) SUBTALAR IMPLANT SYSTEM?

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 NUGAIT(TM) SUBTALAR IMPLANT SYSTEM?

The FDA product code for NUGAIT(TM) SUBTALAR IMPLANT SYSTEM is HWC. This falls under the Cardiovascular category.

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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 SYSTEMK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTK112278ASCENSION NUGRIP CMC IMPLANT

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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