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FDA 510(k)

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000

K-Number: K101934 · 2011-08-03

ApplicantMedshape Solutions
Decision Date2011-08-03
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 is the device name listed in this FDA 510(k) record. The listed applicant is Medshape Solutions. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K101934. 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 DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000?

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is Medshape Solutions. The 510(k) number is K101934.

When did DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 receive FDA 510(k) clearance?

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 received FDA 510(k) clearance on 2011-08-03, under 510(k) number K101934.

Who is the listed applicant for DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000?

The FDA 510(k) record lists Medshape Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000?

The FDA product code for DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 is HSB.

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 Medshape Solutions 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.

K101808SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNERK092914WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURESK091202WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,K083792WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055

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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