FDA.reportPublic FDA data

MEDSHAPE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075937223007593722MEDSHAPE, INC.1N2026-01-011575 NORTHSIDE DR NW STE 440 Atlanta GA US 30318

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1021521151436232K260995DynaNail Helix® Fixation SystemHWC2026-09-23
1021521478360882K250628DynaNail TTC Fusion SystemHSB2025-09-12
1021521809377793K220812DynaClip® Bone StapleJDR2022-08-19
1021521363826607K203595DynaFuse Fixation SystemHWC2022-01-04
1021521830713638K203381Dynanail Mini HybridHWC2021-01-15
1021521116105685K193305DynaClip Bone StapleJDR2020-04-23
1021521321021806K182677DynaNail MiniHWC2019-02-14
1021521306633247K181781DynaClipTM Bone StapleJDR2018-11-05
1021521077463179K171376DynaNail TTC Fusion SystemHSB2017-11-02
1021521010549552K151580D.N.E. External Fixation SystemKTT2016-02-16
1021521523986798K141420FASTFORWARDHTN2014-12-18
1021521041650895K141290HELICAL RIDGE PEEK INTERFERENCE SCREWHWC2014-09-29
1021521200864014K140158S.E.A.L. FRACTURE FUSION TUBEKTT2014-05-29
1021521926028694K132783EXOSHAPE DUO SOFT TISSUE FASTENERMBI2013-12-09
1021521654579470K130467POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTUREMBI2013-12-05
1021521997818078K123350ECLIPSE SOFT TISSUE FASTENERMBI2013-03-07
1021521918834614K113828DYNANAIL ANKLE ARTHRODESIS NAILHSB2012-02-29
1021521577207798K113106DNE EXTERNAL FIXATION SYSTEMKTT2012-01-04
1021521350968738K111471EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)MBI2011-06-10
1021521626493821K101934DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000HSB2011-08-03
1021521287531072K101808SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNERHWC2010-11-08
1021521459709659K092914WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURESMBI2009-12-09
1021521969161102K091202WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,HWC2009-09-16
1021521058407266
1021521115610858
1021521214593686
1021521290838670
1021521527589056
1021521699590536
1021521868613366

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC72026-09-23
MBI52013-12-09
HSB42025-09-12
JDR32022-08-19
KTT32016-02-16
HTN12014-12-18

PMN#

GUDID#

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