201-73-02

GUDID 10885862044976

TIBIAL TRAPEZOID TAMP, WITH 12mm x 11mm STEM

Exactech, Inc.

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID10885862044976
NIH Device Record Key10da45c4-04be-4f88-8350-eac4cd7c0cea
Commercial Distribution StatusIn Commercial Distribution
Version Model Number201-73-02
Catalog Number201-73-02
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 Usefalse
Lot Batchtrue
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 Dimensions

Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter
Length11 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862044976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


[10885862044976]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

Devices Manufactured by Exactech, Inc.

10885862653260 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 1
10885862653277 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 2
10885862653284 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 3
10885862653291 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 4
10885862653307 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 5
10885862653321 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 1.5
10885862653338 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 2.5
10885862653345 - Truliant2025-01-16 Special Universal Baseplate Tibial Trial, Size 3.5

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