FDA.report

Apex

Primary DI
05391529586751
Brand
Apex
Company
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Model
F04-850300
Catalog number
F04-850300
Device description
Apex Femoral Nail GT Right Ø 8.5 x 300mm
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05391529586751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05391529586751053915295867515391529586751

GMDN Terms

TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Ambient Storage and Handling

Sterilization Methods

Method

Contacts

PhoneEmail
646-661-3167customercare@orthoxel.com

Regulatory Flags

DUNS number
985596830
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05391529588786ApexINS-1197INS-11972023-07-11
05391529588793ApexINS-1198INS-11982023-07-11
05391543064273ApexINS-1191INS-11912023-07-11
05391529587970ApexF05-100460F05-1004602023-07-10
05391529587987ApexF05-110240F05-1102402023-07-10
05391529587994ApexF05-110260F05-1102602023-07-10
05391529588007ApexF05-110280F05-1102802023-07-10
05391529588014ApexF05-110300F05-1103002023-07-10
05391529588021ApexF05-110320F05-1103202023-07-10
05391529588038ApexF05-110340F05-1103402023-07-10
05391529588045ApexF05-110360F05-1103602023-07-10
05391529588052ApexF05-110380F05-1103802023-07-10
05391529588069ApexF05-110400F05-1104002023-07-10
05391529588076ApexF05-110420F05-1104202023-07-10
05391529588083ApexF05-110440F05-1104402023-07-10
05391529588090ApexF05-110460F05-1104602023-07-10
05391529588106ApexF05-115240F05-1152402023-07-10
05391529588113ApexF05-115260F05-1152602023-07-10
05391529588120ApexF05-115280F05-1152802023-07-10
05391529588137ApexF05-115300F05-1153002023-07-10

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