FDA.reportPublic FDA data

Pathfinder™ ACL System

Primary DI
00850039930058
Brand
Pathfinder™ ACL System
Company
Danamed, Inc.
Model
0180R
Catalog number
0180R
Device description
Pathfinder ACL Guide, Left Knee, 8 mm offset
Published
2023-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039930058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039930058008500399300588500399300580850039930058

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080919105
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850039930065Pathfinder™ ACL System024GP2023-02-28
10850039930062Pathfinder™ ACL System024GP2023-02-28
20850039930069Pathfinder™ ACL System024GP2023-02-28
30850039930066Pathfinder™ ACL System024GP2023-02-28
40850039930063Pathfinder™ ACL System024GP2023-02-28
50850039930060Pathfinder™ ACL System024GP2023-02-28
00850039930003Pathfinder™ ACL System0155R0155R2023-02-16
00850039930010Pathfinder™ ACL System0155L0155L2023-02-16
00850039930027Pathfinder™ ACL System0170R0170R2023-02-16
00850039930034Pathfinder™ ACL System0170L0170L2023-02-16
00850039930041Pathfinder™ ACL System0180R0180R2023-02-16

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Primary DI, Brand, Company table
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00860011177852Wright-Out Hip Stem Extractor 5/64" T-Handle Hex KeyMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177869Wright-Out Hip Stem Extractor 10mm T-Handle Socket WrenchMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
03770019503416Drill - Screw D.3,5mm-L.18SC MEDICALXH2026-07-03
03770019503867Cannulated Screwdriver tip for screw D3,5mm-L.16SC MEDICALXH2026-07-03
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