FDA.reportPublic FDA data

FO NX Nail System

Primary DI
09353903012542
Brand
FO NX Nail System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
APN000268
Catalog number
KWDT-08070/5
Device description
0.8 Double-ended Trocar K-wire 70 mm 5/pkg
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903012542PrimaryGS10
09353903012450Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903012542093539030125429353903012542
09353903012450093539030124509353903012450

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
744008914
Device count
5
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
09353903030218Griplasty SystemGPIsGPIs2026-06-24
09353903016311NX Nail SystemNXNC2045sNXNC2045s2026-04-13
09353903016328NX Nail SystemNXNC2050sNXNC2050s2026-04-13
09353903030003Griplasty SystemGPBOTNGPBOTN2024-09-19
09353903015376NX Nail SystemNXNC2012sNXNC2012s2023-07-16
09353903015383NX Nail SystemNXNC2014sNXNC2014s2023-07-16
09353903015390NX Nail SystemNXNC2016sNXNC2016s2023-07-16
09353903015406NX Nail SystemNXNC2018sNXNC2018s2023-07-16
09353903015413NX Nail SystemNXNC2020sNXNC2020s2023-07-16
09353903015420NX Nail SystemNXNC2022sNXNC2022s2023-07-16
09353903015437NX Nail SystemNXNC2024sNXNC2024s2023-07-16
09353903015444NX Nail SystemNXNC2026sNXNC2026s2023-07-16
09353903015451NX Nail SystemNXNC2028sNXNC2028s2023-07-16
09353903015468NX Nail SystemNXNC2030sNXNC2030s2023-07-16
09353903015475NX Nail SystemNXNC2032sNXNC2032s2023-07-16
09353903015482NX Nail SystemNXNC2034sNXNC2034s2023-07-16
09353903015499NX Nail SystemNXNC2036sNXNC2036s2023-07-16
09353903015505NX Nail SystemNXNC2038sNXNC2038s2023-07-16
09353903015512NX Nail SystemNXNC2040sNXNC2040s2023-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
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00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22