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FDA 510(k)

ASCENSION NUGRIP CMC IMPLANT

K-Number: K112278 · 2011-11-04

ApplicantAscension Orthopedic
Decision Date2011-11-04
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION NUGRIP CMC 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 2011-11-04 under 510(k) number K112278. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENSION NUGRIP CMC IMPLANT?

ASCENSION NUGRIP CMC IMPLANT is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Ascension Orthopedic. The 510(k) number is K112278.

When did ASCENSION NUGRIP CMC IMPLANT receive FDA 510(k) clearance?

ASCENSION NUGRIP CMC IMPLANT received FDA 510(k) clearance on 2011-11-04, under 510(k) number K112278.

Who is the listed applicant for ASCENSION NUGRIP CMC 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 ASCENSION NUGRIP CMC IMPLANT?

The FDA product code for ASCENSION NUGRIP CMC IMPLANT is KYI.

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 SYSTEMK112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTK111799NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

Related Devices (Code: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant ABK061954ARTELON CMC SPACER ARTHROArtimplant AB

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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