FDA.reportPublic FDA data

HiMAX Plus Implant System

Primary DI
00815432027675
Brand
HiMAX Plus Implant System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
HiMAX Plus Single Packaged Implant, 18mm x 18mm x
Catalog number
7418-1818
Device description
The HiMAX Plus Implant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
Published
2019-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432027675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432027675008154320276758154320276750815432027675

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-221-8406info@crextremity.com

Regulatory Flags#

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112596793TriLeap Lower Extremity Anatomic Plating System04.900.151049001512026-02-19
00810112597202TriLeap Lower Extremity Anatomic Plating System04.913.035049130352026-02-19
00810112597219TriLeap Lower Extremity Anatomic Plating System04.913.040049130402026-02-19
00810112597226TriLeap Lower Extremity Anatomic Plating System04.913.045049130452026-02-19
00810112597233TriLeap Lower Extremity Anatomic Plating System04.913.050049130502026-02-19
00810112597240TriLeap Lower Extremity Anatomic Plating System04.913.055049130552026-02-19
00810112597257TriLeap Lower Extremity Anatomic Plating System04.913.060049130602026-02-19
00810112597264TriLeap Lower Extremity Anatomic Plating System04.913.065049130652026-02-19
00810112597271TriLeap Lower Extremity Anatomic Plating System04.914.035049140352026-02-19
00810112597288TriLeap Lower Extremity Anatomic Plating System04.914.040049140402026-02-19
00810112597295TriLeap Lower Extremity Anatomic Plating System04.914.050049140502026-02-19
00810112597301TriLeap Lower Extremity Anatomic Plating System04.914.045049140452026-02-19
00810112597318TriLeap Lower Extremity Anatomic Plating System04.914.055049140552026-02-19
00810112597325TriLeap Lower Extremity Anatomic Plating System04.914.060049140602026-02-19
00810112597332TriLeap Lower Extremity Anatomic Plating System04.914.065049140652026-02-19
00810112598933TriLeap Lower Extremity Anatomic Plating System04.900.118049001182026-02-19
00810112598940TriLeap Lower Extremity Anatomic Plating System04.900.119049001192026-02-19
00810112598957TriLeap Lower Extremity Anatomic Plating System04.900.120049001202026-02-19
00810112598964TriLeap Lower Extremity Anatomic Plating System04.900.121049001212026-02-19
00810112598971TriLeap Lower Extremity Anatomic Plating System04.900.122049001222026-02-19

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