FDA.reportPublic FDA data

FO NX Nail System

Primary DI
09353903006466
Brand
FO NX Nail System
Company
FIELD ORTHOPAEDICS PTY LTD
Model
APN000240
Catalog number
NXDL(c)-200/1
Device description
2.0 Thermally Hardened Cannulated Drill Bit 1/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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09353903006466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09353903006466093539030064669353903006466

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
744008914
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09353903001805FO Micro Screw SystemBTSC00077BTSC000772020-05-19
09353903001812FO Micro Screw SystemBTSC00078BTSC000782020-05-19
09353903001829FO Micro Screw SystemBTSC00079BTSC000792020-05-19
09353903001836FO Micro Screw SystemBTSC00080BTSC000802020-05-19
09353903001843FO Micro Screw SystemBTSC00081BTSC000812020-05-19
09353903001850FO Micro Screw SystemBTSC00082BTSC000822020-05-19
09353903001867FO Micro Screw SystemBTSC00083BTSC000832020-05-19
09353903001874FO Micro Screw SystemBTSC00084BTSC000842020-05-19
09353903001881FO Micro Screw SystemBTSC00085BTSC000852020-05-19
09353903001898FO Micro Screw SystemBTSC00086BTSC000862020-05-19
09353903001904FO Micro Screw SystemBTSC00087BTSC000872020-05-19
09353903001911FO Micro Screw SystemBTSC00088BTSC000882020-05-19
09353903002079FO Micro Screw SystemBTSC00006BTSC000062020-05-19
09353903002086FO Micro Screw SystemBTSC00007BTSC000072020-05-19
09353903002093FO Micro Screw SystemBTSC00008BTSC000082020-05-19
09353903002109FO Micro Screw SystemBTSC00009BTSC000092020-05-19
09353903002116FO Micro Screw SystemBTSC00010BTSC000102020-05-19
09353903002123FO Micro Screw SystemBTSC00011BTSC000112020-05-19
09353903002130FO Micro Screw SystemBTSC00012BTSC000122020-05-19
09353903002147FO Micro Screw SystemBTSC00013BTSC000132020-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24