FDA.reportPublic FDA data

Stapix Superelastic Nitinol Staple System

Primary DI
10815375021706
Brand
Stapix Superelastic Nitinol Staple System
Company
Restore Surgical LLC
Model
SK181616
Published
2015-10-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
10815375021706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081537502170610815375021706

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
792932626
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
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
10815375020020Mini Cannulated Titanium Headed and Headless Screw SetIC25122015-10-17
10815375020037Mini Cannulated Titanium Headed and Headless Screw SetIC25142015-10-17
10815375020044Mini Cannulated Titanium Headed and Headless Screw SetIC25162015-10-17
10815375020051Mini Cannulated Titanium Headed and Headless Screw SetIC25182015-10-17
10815375020068Mini Cannulated Titanium Headed and Headless Screw SetIC25202015-10-17
10815375020075Mini Cannulated Titanium Headed and Headless Screw SetIC25222015-10-17
10815375020082Mini Cannulated Titanium Headed and Headless Screw SetIC25242015-10-17
10815375020099Mini Cannulated Titanium Headed and Headless Screw SetIC25262015-10-17
10815375020105Mini Cannulated Titanium Headed and Headless Screw SetIC25282015-10-17
10815375020112Mini Cannulated Titanium Headed and Headless Screw SetIC25302015-10-17
10815375020129Mini Cannulated Titanium Headed and Headless Screw SetIC25322015-10-17
10815375020136Mini Cannulated Titanium Headed and Headless Screw SetIC25342015-10-17
10815375020143Mini Cannulated Titanium Headed and Headless Screw SetIC25362015-10-17
10815375020150Mini Cannulated Titanium Headed and Headless Screw SetIC25382015-10-17
10815375020167Mini Cannulated Titanium Headed and Headless Screw SetIC25402015-10-17
10815375020174Mini Cannulated Titanium Headed and Headless Screw SetIC30102015-10-17
10815375020181Mini Cannulated Titanium Headed and Headless Screw SetIC30122015-10-17
10815375020198Mini Cannulated Titanium Headed and Headless Screw SetIC30142015-10-17
10815375020204Mini Cannulated Titanium Headed and Headless Screw SetIC30162015-10-17
10815375020211Mini Cannulated Titanium Headed and Headless Screw SetIC30182015-10-17

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Primary DI, Brand, Company table
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