FDA.reportPublic FDA data

DynaNail Helix, Washer, 15 mm

Primary DI
M97033000015150
Brand
DynaNail Helix, Washer, 15 mm
Company
Medshape, Inc.
Model
3300-00-1515
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203595000DynaFuse Fixation SystemMedShape, Inc.2022-01-04HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M97033000015150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, sterileA sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Regulatory Flags#

DUNS number
601306413
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M97012000112300DynaNail1200-01-12302026-10-16
00190446960300DYNANAIL HELIX3100-13-00012026-10-09
00190446960317Active Adaptive3100-14-00012026-10-09
00190446960324DYNANAIL HELIX3100-15-00012026-10-09
00190446960331DYNANAIL HELIX3100-16-00012026-10-09
00190446960348DYNANAIL HELIX3100-17-00452026-10-09
00190446960355DYNANAIL HELIX3100-18-00012026-10-09
00190446960362DYNANAIL HELIX3100-19-00012026-10-09
00190446960379DYNANAIL HELIX3100-20-00012026-10-09
00190446960386Active Adaptive3100-21-00012026-10-09
00190446960393DYNANAIL HELIX3100-22-00012026-10-09
00190446960409DYNANAIL HELIX3100-17-00552026-10-09
00190446960416DYNANAIL HELIX3100-17-00652026-10-09
00190446907466EF1916-07-00012026-06-25
00190446907473EF1916-07-00022026-06-25
M97015000009200Eclipse1500-00-09202017-02-16
M97015000004100Eclipse1500-00-04102017-05-19
M97015000004170Eclipse1500-00-04172017-02-16
M97015000005120Eclipse1500-00-05122017-05-19
M97015000005200Eclipse1500-00-05202017-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543085PC Fix Thoracic Plate 95mm PEEKChest Wall Innovations, Inc.HTN2026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QCChest Wall Innovations, Inc.HTN2026-06-01
00850080543108PC Fix Graphic CaseChest Wall Innovations, Inc.HTN2026-06-01
00850080543115PC Fix Clamp/Drill Guide TopChest Wall Innovations, Inc.HTN2026-06-01
00850080543122PC Fix Clamp/Drill Guide BottomChest Wall Innovations, Inc.HTN2026-06-01
00850080543139PC Fix Compression ClampChest Wall Innovations, Inc.HTN2026-06-01
00850080543146PC Fix 3.2mm Drill Dental LatchChest Wall Innovations, Inc.HTN2026-06-01
00850080543184PC Fix Implant CaddyChest Wall Innovations, Inc.HTN2026-06-01
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
B56251201WR0070T00WishBone Plate & Screw SystemWishbone Medical, Inc.HTN2022-07-18
B56251201WR0070T10WishBone Plate & Screw SystemWishbone Medical, Inc.HTN2022-07-18
00863176000317FIBULINKSynthes GmbHHTN2020-03-26
00888867251960Arthrex®ARTHREX, INC.HTN2017-11-28
00889024483668NCB®Zimmer GmbHHTN2017-07-28
00863176000300FIBULINKSynthes GmbHHTN2017-06-08
00888867196537Arthrex®ARTHREX, INC.HTN2017-05-11
00888867196582Arthrex®ARTHREX, INC.HTN2017-05-11
00888867251939Arthrex®ARTHREX, INC.HTN2017-02-15
00888867026599Arthrex®ARTHREX, INC.HTN2017-02-15
10845854015506CONMEDConmed CorporationHTN2015-12-10
10845854015865CONMEDConmed CorporationHTN2015-12-10
10845854015957CONMEDConmed CorporationHTN2015-12-10