FDA.reportPublic FDA data

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Primary DI
03701037313435
Brand
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Company
FX SOLUTIONS
Model
906-0025
Catalog number
906-0025
Device description
GLENOID RESURFACING REAMER Ø40mm WITH DRILL/ HUDSON
Published
2020-06-25
Public version status
Update
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
03701037313435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037313435037010373134353701037313435

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light and sunlight Store away from moisture

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263076196
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENT961-0017961-00172026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8803951-88032026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8806951-88062026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8809951-88092026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8812951-88122026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8815951-88152026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8818951-88182026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9803951-98032026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9806951-98062026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9809951-98092026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9812951-98122026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9815951-98152026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9818951-98182026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9909951-99092026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9912951-99122026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9915951-99152026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9918951-99182026-06-26
03701037300718HUMELOCK903-4036903-40362026-06-25
03701037307007Humelock II Cementless Shoulder System926-1025926-10252026-06-25
03701037307984HUMELOCK903-4440903-44402026-06-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
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