FDA.reportPublic FDA data

OrthAlign Plus

Primary DI
00810832031055
Brand
OrthAlign Plus
Company
Orthalign, Inc.
Model
402149
Catalog number
402149
Device description
Vanguard - Balance Interchangeable Drill Plate
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
00810832031055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810832031055008108320310558108320310550810832031055

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
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
00810832031697Lantern Surgical Assistant402519-06402519-062023-09-01
00810832031710Lantern Surgical Assistant402528-01402528-012023-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
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00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02