FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912095020
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
803-08-106
Device description
CLP STEM MONO BROACH #6
Published
2024-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTQBROACH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912095020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912095020008889120950208889120950200888912095020

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446776550DJO SURGICAL800-99-1632025-01-17
00190446776567DJO SURGICAL800-99-1642025-01-17
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446706304DJO SURGICAL800-99-1482022-10-18
00190446706311DJO SURGICAL800-99-1492022-10-18
00190446706328DJO SURGICAL800-99-1512022-10-18
00190446706335DJO SURGICAL800-99-1522022-10-18
00190446757665DJO SURGICAL800-99-1592022-08-17
00190446757672DJO SURGICAL800-99-1602022-08-17
00190446764274DJO SURGICAL800-99-1612022-08-17
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
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00885556871454AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871461AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
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00885556871485AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556811924AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811931AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811948AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811955AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811962AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556856505Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856512Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856529Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856536Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856543Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856550Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02