FDA.reportPublic FDA data

OrthAlign Plus

Primary DI
00810832031109
Brand
OrthAlign Plus
Company
Orthalign, Inc.
Model
402154
Catalog number
402154
Device description
Sigma - Balance Interchangeable Drill Plate - Large
Published
2021-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172462000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172462000OrthAlign Plus SystemOrthalign, Inc.2017-11-22OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810832031109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810832031109008108320311098108320311090810832031109

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
866-582-0879customerservice@orthalign.com

Regulatory Flags#

DUNS number
023266163
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810832032601Lantern ASC5030005030002026-09-30
00810832032618Lantern ASC407001-02407001-022026-09-30
00858704006558OrthAlign Plus403008-01403008-012016-09-23
00810832032328Lantern4035974035792025-12-29
00810832032243Lantern4035794035792025-11-19
00810832032489Lantern502000-02502000-022025-12-12
00810832032182Lantern4053104053102025-12-09
00810832031994Lantern502000-01502000-012025-09-12
00810832032403Lantern4025644025642025-11-12
00810832032410Lantern4025654025652025-11-12
00810832032427Lantern4025664025662025-11-12
00810832032434Lantern4025674025672025-11-12
00810832032472Lantern4025704025702025-11-12
00810832031581Lantern Surgical Assistant (LSA)4025054025052023-01-31
00810832032007Lantern Surgical Assistant (LSA)405204-KA405204-KA2023-11-21
00810832031642Lantern Surgical Assistant402519-01402519-012023-09-01
00810832031659Lantern Surgical Assistant402519-02402519-022023-09-01
00810832031666Lantern Surgical Assistant402519-03402519-032023-09-01
00810832031673Lantern Surgical Assistant402519-04402519-042023-09-01
00810832031680Lantern Surgical Assistant402519-05402519-052023-09-01

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Primary DI, Brand, Company table
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00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres LBrainlab SEOLO2026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
04056481147693Quip Instrument Adapter Clamp Size SBrainlab SEOLO2026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size MBrainlab SEOLO2026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size LBrainlab SEOLO2026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular InstrumentsBrainlab SEOLO2026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
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00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
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00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
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