FDA.reportPublic FDA data

NA

Primary DI
03700879513638
Brand
NA
Company
NOVASTEP
Model
CKW02007
Catalog number
CKW02007
Device description
K-Wire Ø1,2 lg100 TR/RD CoCr
Published
2021-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879513638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879513638037008795136383700879513638

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33299338650contact@novastep-ortho.com
+33299338650regulatory-IntFA@enovis.com

Regulatory Flags#

DUNS number
264255288
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700879515540airlock®XDB01027XDB010272026-07-10
03700879518701NAXMS01056XMS010562026-06-23
03700879518718NAXMS01057XMS010572026-06-23
03700879518725NAXMS01058-1XMS01058-12026-06-23
03700879518732NAXMS01058-2XMS01058-22026-06-23
03700879518565PECAPLASTY®ACC1025P0001ACC1025P00012026-03-19
03700879518572PECAPLASTY®ACC1025P0002ACC1025P00022026-03-19
03700879518589PECAPLASTY®XMS01055-1XMS01055-12026-03-19
03700879518596PECAPLASTY®XMS01055-2XMS01055-22026-03-19
03700879516479arcad® 2.0CSK101012CSK1010122024-08-08
03700879516486arcad® 2.0CSK121212CSK1212122024-04-16
03700879516493arcad® 2.0CSK151515CSK1515152024-04-16
03700879516509arcad® 2.0CSK181818CSK1818182024-04-16
03700879516516arcad® 2.0CSK202020CSK2020202024-04-16
03700879516523arcad® 2.0CSK252020CSK2520202024-04-16
03700879516530arcad® 2.0CSK261818CSK2618182024-04-16
03700879516547arcad® 2.0CSK302020CSK3020202024-04-16
03700879516554arcad® 2.0CSK301612CSK3016122024-04-16
03700879500386arcad®CS010909CS0109092015-10-16
03700879500393arcad®CS011214CS0112142015-10-16

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00841731153135ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
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00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
03700879515540airlock®NOVASTEPHWE2026-07-10
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04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
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04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
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