FDA.reportPublic FDA data

OrthAlign Plus

Primary DI
00810832031369
Brand
OrthAlign Plus
Company
Orthalign, Inc.
Model
403001-08
Catalog number
403001-08
Device description
OrthAlign Plus Unit - Gap Balancing
Published
2021-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K130387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130387000ORTHOALIGN PLUS SYSTEMOrthalign, Inc.2013-11-08OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810832031369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810832031369008108320313698108320313690810832031369

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
Storage Environment Atmospheric Pressure60 KiloPascal101 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
023266163
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13