OrthAlign Plus 403430-10

GUDID 00810832030737

Universal RS Adapter, Large- .735” – 1.250”

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810832030737
NIH Device Record Key074f54eb-aa8b-4f9b-89bc-7b23672ce220
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthAlign Plus
Version Model Number403430-10
Catalog Number403430-10
Company DUNS023266163
Company NameORTHALIGN, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-582-0879
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100810832030737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810832030737]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

On-Brand Devices [OrthAlign Plus]

00810832030423HipAlign Inst Set: Universal Hip Set
00810832030416HipAlign Inst Set: DA HipAlign Set w/ 90mm pins
00810832030409HipAlign Inst Set: DA HipAlign Set
00810832030379Fixation Pin, 4.0mm DIA x 90mm, 3.2mm Proximal End, 2-Pack, N/S
00810832030362Universal Adapter, Clip, 17.6mm
00810832030355Impactor, Straight, 4 Position, S/B
00810832030348Impactor, Straight, 4 Position, S&N
00810832030331Impactor, Straight, 4 Position, 1/4-28 DJO
00810832030324Impactor, Straight, 4 Position, 7/16-20, DPY
00810832030317Universal RS Adapter, Large- .485"-.750"
00810832030300Universal RS Adapter, Small- .325"-.500"
00810832030294Adapter,Implant,Off Impactr, M8x1.25, LIM
00810832030287Implant Adapter, Magnetic, 9/16-7/8
00810832030270Implant Adapter, Magnetic, 3/8-1/2
00810832030249HIPALIGN INST. SET: DAA LL – Core Set
00810832030188Impactor, Straight, Unibody, M10 x 1.5, MAX
00810832030171Impactor, Straight, Unibody, ¼-28, DJO
00810832030164Impactor, Straight, Unibody, 3/8-32, WT
00810832030157Impactor, Straight, Unibody, 5/16-24, ZIM
00810832030140Impactor, Straight, Unibody, 3/8-16, S&N
00810832030133Impactor, Straight, Unibody, 3/8-24, S/B
00810832030126Impactor, Straight, Unibody, 7/16-20, DPY
00810832030102Adapter,Implant,Str Impactr,M8x1.25,LIM
00810832030096Impactor System Adapter, Lima
00810832030089OrthAlign Plus Unit - Gap Balancing
00810832030065Threaded Fixation Pin, 4.0 mm x 90mm, 3.2mm Proximal End
00810832030041HIPALIGN INST. SET: DA/Supine Cup Placement
00810832030034HIPALIGN INST. SET: DAA LL- Offset Impactor -03 Tray
00810832030027HIPALIGN INST. SET: DAA LL- Straight Impactor -03 Tray
00810832030010HIPALIGN INST. SET: DAA LL – US ONLY
00810832030003KTIS Calibration Bracket
00858704006992Adapter,Implant,Off Impactr,M10X1.5,MAXX
00858704006985Adapter,Implant,Off Impactr,1/4-28,DJO
00858704006978Adapter,Implant,Off Impactr,3/8-32,WT
00858704006961Adapter,Implant,Off Impactr,3/8-16,S&N
00858704006954Pin Driver, Tri-flat, Hudson Connector
00858704006947Probe Mount, 60mm
00858704006930Registration Probe
008587040069235mm Trocar
00858704006916Drill Guide, 140mm Cannula
00858704006909Threaded Fixation Pin, 5MM X 170MM
00858704006893Adapter,Implant,Str Impactr,1/4-28,DJO
00858704006886Adapter,Implant,Str Impactr,M10x1.5,MAX
00858704006879Adapter,Implant,Str Impactr,3/8-32,WT
00858704006862Adapter,Implant,Str Impactr,3/8-16,S&N
00858704006855Adapter,Implant,Str Impactr,7/16-20,DPY
00858704006848Pin, Headless, Smooth, 65 mm
00858704006831UniAlign, Midline Probe, Right
00858704006824UniAlign Midline Probe, Left
00858704006817UniAlign Tibial Jig Body

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