Indy Standalone

GUDID 00843210169200

4.2mm Dia. Drill, 15mm

Altus Spine, LLC

Surgical screwdriver, reusable
Primary Device ID00843210169200
NIH Device Record Keyac8c72dd-290c-4970-89ec-21d9ea00498f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndy Standalone
Version Model Number1030-0230
Company DUNS078331322
Company NameAltus Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210169200 [Primary]

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


[00843210169200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

On-Brand Devices [Indy Standalone]

00843210160030PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210160023PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210160016PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210160009PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210159997PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210159980PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210159973PEEK/Titanium Interbody, 25 °, 32mm x 24mm
00843210159744PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159737PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159720PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159713PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159706PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159690PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159683PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159676PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159669PEEK/Titanium Interbody, 20 °, 32mm x 24mm
00843210159386PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159379PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159362PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159355PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159348PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159331PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159324PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159317PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159300PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210159294PEEK/Titanium Interbody, 16 °, 32mm x 24mm
00843210158969PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158952PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158945PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158938PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158921PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158914PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158907PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158891PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158884PEEK/Titanium Interbody, 12 °, 32mm x 24mm
00843210158877PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158655PEEK/Titanium Interbody, 8 °, 38mm x 27mm
00843210158648PEEK/Titanium Interbody, 8 °, 38mm x 27mm
00843210158471PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158464PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158457PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158440PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158433PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158426PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158419PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158402PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210158396PEEK/Titanium Interbody, 8 °, 32mm x 24mm
00843210160177PEEK/Titanium Interbody, 25 °, 38mm x 27mm
00843210160160PEEK/Titanium Interbody, 25 °, 38mm x 27mm
00843210160153PEEK/Titanium Interbody, 25 °, 38mm x 27mm

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