ExoShape Femoral

GUDID M97016000000808

ExoShape Femoral, 8MM x 21MM

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device IDM97016000000808
NIH Device Record Key05d4596f-914b-4159-b0fb-c94426630144
Commercial Distribution Discontinuation2023-06-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameExoShape Femoral
Version Model Number1600-00-008
Company DUNS601306413
Company NameMedshape, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM97016000000808 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-06-27
Device Publish Date2015-09-22

On-Brand Devices [ExoShape Femoral]

M97016000001102ExoShape Femoral, 11MM x 21MM
M97016000001001ExoShape Femoral, 10MM x 21MM
M97016000000909ExoShape Femoral, 9MM x 21MM
M97016000000808ExoShape Femoral, 8MM x 21MM

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