FDA.reportPublic FDA data

BROACH

Primary DI
00810111227933
Brand
BROACH
Company
Treace Medical Concepts, Inc.
Model
02-00558
Device description
BROACH - SMALL
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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
00810111227933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111227933008101112279338101112279330810111227933

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111227919BROACH02-005602026-09-30
00810111227926BROACH02-005592026-09-30
00810111228527Drill Guide02-006302026-09-21
00810111224680TMC PSI Cut Guide SystemPSI-02-003862025-05-22
00810111224697TMC PSI Cut Guide SystemPSI-02-003852025-05-22
00810111223447TMC PSI Cut Guide SystemNK232024-11-14
00810111223454TMC PSI Cut Guide SystemNK242024-11-14
00810111223478TMC PSI Cut Guide SystemNK262024-11-14
00810111223553TMC PSI Cut Guide SystemPSI-02-002332024-11-15
00810111223560TMC PSI Cut Guide SystemPSI-02-002322024-11-15
00810111223577TMC PSI Cut Guide SystemPSI-02-002312024-11-15
00810111223584TMC PSI Cut Guide SystemPSI-02-002302024-11-15
00810111223621TMC PSI Cut Guide SystemNK272024-11-14
00810111222723TMC PSI Cut Guide SystemPSI-02-001632024-03-11
00810111222730TMC PSI Cut Guide SystemPSI-02-001622024-03-11
00810111222259TMC PSI Cut Guide SystemNK152023-11-17
00810111222266TMC PSI Cut Guide SystemPSI-01-2029-0212023-11-17
00810111222273TMC PSI Cut Guide SystemPSI-01-2229-0212023-11-17
00810111222280TMC PSI Cut Guide SystemPSI-01-2129-0212023-11-17
00810111222297TMC PSI Cut Guide SystemPSI-01-2329-0212023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227919BROACHTreace Medical Concepts, Inc.HTQ2026-09-30
00810111227926BROACHTreace Medical Concepts, Inc.HTQ2026-09-30
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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00885556871461AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871478AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
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