FDA.reportPublic FDA data

NanoPhix Instrument Kit

Primary DI
B487EXINN9115000
Brand
NanoPhix Instrument Kit
Company
Exsomed Corporation
Model
EXINN911500
Catalog number
EXINN911500
Device description
NanoPhix sterile instrument kit. The kit contains 1 depth gauge, 2 guide wires, 1 driver.
Published
2022-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTJGauge, Depth
HXIPasser, Wire, Orthopedic
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1
HXIPasser, Wire, OrthopedicOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B487EXINN9115000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced; or 3) a cylindrical rod with markings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116722111
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B487EXINN9215060NanoPhix ImplantEXINN921506EXINN9215062022-11-01
B487EXINN9215070NanoPhix ImplantEXINN921507EXINN9215072022-11-01
B487EXINN9215080NanoPhix ImplantEXINN921508EXINN9215082022-11-01
B487EXINN9215090NanoPhix ImplantEXINN921509EXINN9215092022-11-01
B487EXINN9215100NanoPhix ImplantEXINN921510EXINN9215102022-11-01
B487EXINN9215110NanoPhix ImplantEXINN921511EXINN9215112022-11-01
B487EXINN9215120NanoPhix ImplantEXINN921512EXINN9215122022-11-01
B487EXINN9215130NanoPhix ImplantEXINN921513EXINN9215132022-11-01
B487EXINN9215140NanoPhix ImplantEXINN921514EXINN9215142022-11-01
B487EXINN9215150NanoPhix ImplantEXINN921515EXINN9215152022-11-01
B487EXINN9215160NanoPhix ImplantEXINN921516EXINN9215162022-11-01
B487EXINN9215170NanoPhix ImplantEXINN921517EXINN9215172022-11-01
B487EXINN9215180NanoPhix ImplantEXINN921518EXINN9215182022-11-01
B487EXINN9215190NanoPhix ImplantEXINN921519EXINN9215192022-11-01
B487EXINN9215200NanoPhix ImplantEXINN921520EXINN9215202022-11-01
B487EXINN9215210NanoPhix ImplantEXINN921521EXINN9215212022-11-01
B487EXINN9215220NanoPhix ImplantEXINN921522EXINN9215222022-11-01
B487EXINN9215230NanoPhix ImplantEXINN921523EXINN9215232022-11-01
B487EXINN9215240NanoPhix ImplantEXINN921524EXINN9215242022-11-01
B487EXINN9215250NanoPhix ImplantEXINN921525EXINN9215252022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000885502MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-11
00190446960300DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00190446960317Active AdaptiveMedshape, Inc.LXH2026-10-09
00190446960355DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00190446960393DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00198506095771ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00198506095788ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00810155330781Tigon MedicalTigon Medical LLCLXH2026-10-09
08056711926636Orthopaedic Manual Surgical InstrumentsCITIEFFE SRLLXH2026-10-09
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
00190776433666MillenniumAvalign Technologies, Inc.LXH2026-10-07
00810017915972T-Handle, 1/4" Sq, RatchetingELEVATION SPINE, INC.LXH2026-10-07
00810017915996Torque Limiting Expansion Driver Handle, 3.0NmELEVATION SPINE, INC.LXH2026-10-07
00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
B7685216080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.LXH2026-10-06
00810228161731corraCarlsmed, Inc.LXH2026-10-05
00840493441641LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01