140-36-93

GUDID 10885862025586

Exactech, Inc.

Ceramic femoral head prosthesis
Primary Device ID10885862025586
NIH Device Record Keyc397c34b-ca11-4ba4-adc2-343474b064ef
Commercial Distribution StatusIn Commercial Distribution
Version Model Number140-36-93
Catalog Number140-36-93
Company DUNS157565946
Company NameExactech, 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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter
Device Size Text, specify0
Outer Diameter36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862025586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-09
Device Publish Date2017-06-27

Devices Manufactured by Exactech, Inc.

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10885862655646 - Vantage2025-04-15 Special Vantage Sharp Reamer, Straight Blade, Cone Tip - 15mm Tall x 12mm Diameter
10885862655653 - Vantage2025-04-15 Special Vantage Sharp Reamer, Helix Blade, Flat Tip - 15mm Tall x 12mm Diameter
10885862655660 - Vantage2025-04-15 Special Vantage Sharp Reamer, Helix Blade, Cone Tip - 15mm Tall x 12mm Diameter
10885862604699 - Equinoxe2025-03-28 Humeral Reconstruction Prothesis MIDDLE SEGMENT TRIAL, 25mm
10885862604705 - Equinoxe2025-03-28 Humeral Reconstruction Prothesis MIDDLE SEGMENT TRIAL, 50mm
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