InCore Lapidus

GUDID 00817701021025

InCore Lapidus 3.5mm X 40mm Titanium Screw

NEXTREMITY SOLUTIONS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00817701021025
NIH Device Record Key93dcf9fb-7c4f-4b03-917f-64845e341704
Commercial Distribution StatusIn Commercial Distribution
Brand NameInCore Lapidus
Version Model NumberIC-LAP-3540
Company DUNS060783407
Company NameNEXTREMITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817701021025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-04
Device Publish Date2018-08-23

On-Brand Devices [InCore Lapidus]

00817701021384InCore Lapidus Torque Limiting Handle
00817701021353Lapidus Replacement Compression Screw Reusable
00817701021346Lapidus Replacement Compression Frame Reusable
00817701021322Instrument Case Lid Reusable
00817701021315Instrument Case Reusable
00817701021308Ratchet Handle Reusable
00817701021292Depth Probe Reusable
00817701021285Removal Fastener Reusable
00817701021278Removal Slap Hammer Reusable
00817701021261Removal Drill Guide Reusable
008177010212543.6mm Drill Bit Reusable
00817701021247T10 Driver Reusable
008177010212305.9mm Post Drill Reusable
00817701021223Post Fastener Reusable
00817701021216Drill Bushing 70mm Reusable
00817701021209Drill Bushing 55mm Reusable
00817701021193Drill Bushing 40mm Reusable
008177010211862mm X 4" K-Wire
00817701021179Targeting Guide Assembly Right Reusable
00817701021162Targeting Guide Assembly Left Reusable
00817701021155Post Guide Right Reusable
00817701021148Post Guide Left Reusable
00817701021131InCore Lapidus Post Plug Screw
00817701021124InCore Lapidus 3.5mm X 46mm Titanium Screw
00817701021117InCore Lapidus 3.5mm X 60mm Titanium Screw
00817701021100InCore Lapidus 3.5mm X 58mm Titanium Screw
00817701021094InCore Lapidus 3.5mm X 56mm Titanium Screw
00817701021087InCore Lapidus 3.5mm X 54mm Titanium Screw
00817701021070InCore Lapidus 3.5mm X 52mm Titanium Screw
00817701021063InCore Lapidus 3.5mm X 50mm Titanium Screw
00817701021056InCore Lapidus 3.5mm X 48mm Titanium Screw
00817701021049InCore Lapidus 3.5mm X 44mm Titanium Screw
00817701021032InCore Lapidus 3.5mm X 42mm Titanium Screw
00817701021025InCore Lapidus 3.5mm X 40mm Titanium Screw
00817701021018InCore Lapidus 3.5mm X 38mm Titanium Screw
00817701021001InCore Lapidus 3.5mm X 36mm Titanium Screw
00817701020998InCore Lapidus 3.5mm X 34mm Titanium Screw
00817701020981InCore Lapidus 3.5mm X 32mm Titanium Screw
00817701020974InCore Lapidus 3.5mm X 30mm Titanium Screw
00817701020967InCore Lapidus 3.5mm X 28mm Titanium Screw
00817701020950InCore Lapidus 3.5mm X 26mm Titanium Screw
00817701020943InCore Lapidus 3.5mm X 24mm Titanium Screw
00817701020936InCore Lapidus 5.9mm X 32mm Left Titanium Post
00817701020929InCore Lapidus 5.9mm X 32mm Right Titanium Post
00817701020912InCore Lapidus 5.9mm X 28mm Left Titanium Post
00817701020905InCore Lapidus 5.9mm X 28mm Right Titanium Post
00817701020899InCore Lapidus 5.9mm X 32mm Left Kit
00817701020882IC-LAP-32R
00817701020875InCore Lapidus 5.9mm X 28mm Left Kit
00817701020868InCore Lapidus 5.9mm X 28mm Right Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.