Modular Broach Holder, Single Offset

GUDID 00819251020480

Modular Broach Holder, Single Offset

TOTAL JOINT ORTHOPEDICS, INC.

Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00819251020480
NIH Device Record Key921f8553-8e35-43f0-9227-de9c0a4d75fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Broach Holder, Single Offset
Version Model Number1112.00.000
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, 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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100819251020480 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

[00819251020480]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00819251020480 - Modular Broach Holder, Single Offset2024-05-08Modular Broach Holder, Single Offset
00819251020480 - Modular Broach Holder, Single Offset2024-05-08 Modular Broach Holder, Single Offset
00819251020497 - Anterior Starter Broach2024-05-08 Anterior Starter Broach
00810094691851 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 1
00810094691868 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 2 and 3
00810094691875 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 4 and 5
00810094691882 - PS-Post Box Resection Guide2024-02-22 PS-Post Box Resection Guide, Size 6 and 7
00819251021197 - Femoral Stem Impactor with Anteversion 2023-12-19 Femoral Stem Impactor with Anteversion
00819251020503 - Acetabular Cup Sizer2023-12-05 Acetabular Cup Sizer, 48mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.