FDA.reportPublic FDA data

NX Nail System

Primary DI
09353903015376
Brand
NX Nail System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
NXNC2012s
Catalog number
NXNC2012s
Device description
2.0 x 12 mm NX Nail Implant
Published
2023-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230118000Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.2023-02-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903015376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903015376093539030153769353903015376

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from moisture and direct heat.

Regulatory Flags#

DUNS number
744008914
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
true
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
09353903030201Griplasty SystemGPBOTNeGPBOTNe2026-06-24
09353903030218Griplasty SystemGPIsGPIs2026-06-24
09353903016311NX Nail SystemNXNC2045sNXNC2045s2026-04-13
09353903016328NX Nail SystemNXNC2050sNXNC2050s2026-04-13
09353903030003Griplasty SystemGPBOTNGPBOTN2024-09-19
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
09353903001805FO Micro Screw SystemBTSC00077BTSC000772020-05-19

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Primary DI, Brand, Company table
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00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
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