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FDA 510(k)

ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40

K-Number: K061451 · 2006-08-11

ApplicantAscension Orthopedics, Inc.
Decision Date2006-08-11
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 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 2006-08-11 under 510(k) number K061451. 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, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40?

ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 is a medical device that received FDA 510(k) clearance on 2006-08-11. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K061451.

When did ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 receive FDA 510(k) clearance?

ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 received FDA 510(k) clearance on 2006-08-11, under 510(k) number K061451.

Who is the listed applicant for ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40?

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, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40?

The FDA product code for ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 is KYI.

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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: 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, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant 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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