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FDA 510(k)

DYNA LOCKING CANNULATED SCREW

K-Number: K112240 · 2012-01-04

ApplicantU&I Corp.
Decision Date2012-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNA LOCKING CANNULATED SCREW is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corp.. It received FDA 510(k) clearance on 2012-01-04 under 510(k) number K112240. 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 DYNA LOCKING CANNULATED SCREW?

DYNA LOCKING CANNULATED SCREW is a medical device that received FDA 510(k) clearance on 2012-01-04. The listed applicant is U&I Corp.. The 510(k) number is K112240.

When did DYNA LOCKING CANNULATED SCREW receive FDA 510(k) clearance?

DYNA LOCKING CANNULATED SCREW received FDA 510(k) clearance on 2012-01-04, under 510(k) number K112240.

Who is the listed applicant for DYNA LOCKING CANNULATED SCREW?

The FDA 510(k) record lists U&I Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNA LOCKING CANNULATED SCREW?

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

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Other records listing U&I Corp. 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.

K120419DYNA LOCKING ANKLE NAILK102367OPTIGEN TOTAL KNEE SYSTEMK093707DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820K092771DYNA LOCKING IM NAILK091725PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)K061002MAXIMA ANTERIOR CERVICAL PLATE 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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