213-65-35

GUDID 10885862059963

AXIAL PATELLA SAW GUIDE, 35mm RING

Exactech, Inc.

Osteotomy guide, reusable
Primary Device ID10885862059963
NIH Device Record Key4eeecba3-5049-40c7-97d4-e1ba4e39b8d3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number213-65-35
Catalog Number213-65-35
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

Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter
Lumen/Inner Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862059963 [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

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

Moist Heat or Steam Sterilization

[10885862059963]

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.

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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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