FDA.report

NITINEX

Primary DI
00841731138019
Brand
NITINEX
Company
VILEX LLC
Model
SI-1818
Catalog number
SI-1818
Device description
NITINEX Staple Implant System, 18mm x 18mm, Sterile
Published
2024-12-05
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

Product Codes

CodeName
JDRStaple, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K231493000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231493000NITINEX Memory Compression StapleVilex, LLC2023-08-11JDR

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841731138019PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic bone staple, non-adjustableA 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. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
117502293
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

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