FDA.reportPublic FDA data

Orthex

Primary DI
00841132179352
Brand
Orthex
Company
ORTHOPEDIATRICS CORP.
Model
K400-15BNPA
Catalog number
K400-15BNPA
Device description
Pear Wire, Sharp Bayonet, 400mm x 1.5mm, HA Coated (Sterile)
Published
2020-03-02
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
JDWPin, Fixation, Threaded
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132179352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132179352008411321793528411321793520841132179352

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
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
false
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
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032909626380ST.A.R. 90 F4CITIEFFE SRLJDW2026-03-17
00888867516441Arthrex®ARTHREX, INC.JDW2026-03-13
00888867516465Arthrex®ARTHREX, INC.KTT2026-03-13
00888867516472Arthrex®ARTHREX, INC.KTT2026-03-13
00888867518681Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543157Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543256Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543331Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543348Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543355Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543362Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543379Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543386Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543393Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543409Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543478Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543591Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543607Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543638Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543645Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543676Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543690Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543706Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543713Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543799Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543843Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543881Arthrex®ARTHREX, INC.KTT2026-03-13
08051739535730ST.A.R. 90 F4CITIEFFE SRLJDW2026-03-10
00841731149077DYNEX MICROVILEX LLCKTT2026-03-03
00810184540007Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14