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FDA 510(k)

DYNA LOCKING ANKLE NAIL

K-Number: K120419 · 2012-05-21

ApplicantU&I Corp.
Decision Date2012-05-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNA LOCKING ANKLE NAIL 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 2012-05-21 under 510(k) number K120419. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNA LOCKING ANKLE NAIL?

DYNA LOCKING ANKLE NAIL is a medical device that received FDA 510(k) clearance on 2012-05-21. The listed applicant is U&I Corp.. The 510(k) number is K120419.

When did DYNA LOCKING ANKLE NAIL receive FDA 510(k) clearance?

DYNA LOCKING ANKLE NAIL received FDA 510(k) clearance on 2012-05-21, under 510(k) number K120419.

Who is the listed applicant for DYNA LOCKING ANKLE NAIL?

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 ANKLE NAIL?

The FDA product code for DYNA LOCKING ANKLE NAIL is HSB.

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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.

K112240DYNA LOCKING CANNULATED SCREWK102367OPTIGEN 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: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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