FDA.report

NITINEX

Primary DI
00841731139931
Brand
NITINEX
Company
VILEX LLC
Model
SK-2020
Catalog number
SK-2020
Device description
NITINEX Implant Surgical Kit, 20mm x 20mm, 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
KDDKit, Surgical Instrument, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Premarket Submissions

SubmissionSupplement
K231493000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841731139931PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic bone staple drill bitA thin shaft of metal with a sharp distal end intended to drill a small diameter hole into a small bone for insertion of an orthopaedic bone staple, typically for fixation following osteotomy. It may include markings to help gauge the size of the staple to be used and is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

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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