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FDA 510(k)

ASCENSION CANNULATED SCREW SYSTEM

K-Number: K092440 · 2009-11-05

ApplicantAscension Orthopedics, Inc.
Decision Date2009-11-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION CANNULATED SCREW SYSTEM 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 2009-11-05 under 510(k) number K092440. 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 ASCENSION CANNULATED SCREW SYSTEM?

ASCENSION CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K092440.

When did ASCENSION CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

ASCENSION CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2009-11-05, under 510(k) number K092440.

Who is the listed applicant for ASCENSION CANNULATED SCREW SYSTEM?

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 CANNULATED SCREW SYSTEM?

The FDA product code for ASCENSION CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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: 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

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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