DynaNail Helix, Headless, 55mm

GUDID M97032000170550

Medshape, Inc.

Arthrodesis nail, sterile
Primary Device IDM97032000170550
NIH Device Record Key1eed9494-ebdb-47ed-b9ea-baff63f4f281
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaNail Helix, Headless, 55mm
Version Model Number3200-01-7055
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM97032000170550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-26
Device Publish Date2022-04-18

Devices Manufactured by Medshape, Inc.

M9701000032250 - Morphix XT2025-07-29 MORPHIX 2.5mm x 7mm Anchor with two USP
M9701000032350 - Morphix XT2025-07-29 MORPHIX 3.5mm x 8mm Anchor with two USP
M9701000032450 - Morphix XT2025-07-29 MORPHIX 4.5mm x 9mm Anchor with two USP
M9701000041250 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 2.5MM
M9701000042450 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 4.5MM
M9701000042550 - Morphix XT2025-07-29 MORPHIX Foot and Ankle, 5.5MM
M97012000250200 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 20MM
M97012000250220 - DynaNail2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 22.5MM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.