FDA.reportPublic FDA data

Lantern ASC

Primary DI
00810832032618
Brand
Lantern ASC
Company
Orthalign, Inc.
Model
407001-02
Catalog number
407001-02
Device description
Lantern ASC Navigation Unit Kit, Knee and Hip
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONNIntraoperative Orthopedic Joint Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONNIntraoperative Orthopedic Joint Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253507000Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.2026-06-02ONN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810832032618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810832032618008108320326188108320326180810832032618

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
866-582-0879customerService@Orthalign.com

Regulatory Flags#

DUNS number
023266163
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810832032601Lantern ASC5030005030002026-09-30
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
00810832031697Lantern Surgical Assistant402519-06402519-062023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810832032601Lantern ASCOrthalign, Inc.ONN2026-09-30
00810832032328LanternOrthalign, Inc.ONN2025-12-29
00810832032489LanternOrthalign, Inc.ONN2025-12-12
00810832032243LanternOrthalign, Inc.ONN2025-11-19
00810832031994LanternOrthalign, Inc.ONN2025-09-12
00810832032311LanternOrthalign, Inc.ONN2025-05-06
00810832032335LanternOrthalign, Inc.ONN2025-05-06
00810832032229Lantern Orthalign, Inc.ONN2025-04-24
05065012584493Quadsense ProEVENTUM ORTHOPAEDICS LTDONN2025-04-04
05065012584158QuadsenseEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584233Dongle AssemblyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584516Panel PCEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584523TrollyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
00810832031895Lantern Orthalign, Inc.ONN2024-12-13
00810832031901LanternOrthalign, Inc.ONN2024-12-13
00810832031918LanternOrthalign, Inc.ONN2024-12-13
00810832031925LanternOrthalign, Inc.ONN2024-12-13
00810832031932LanternOrthalign, Inc.ONN2024-12-13
00810832032014LanternOrthalign, Inc.ONN2024-12-13
00810832032021Lantern Orthalign, Inc.ONN2024-12-13
00810832032038Lantern Orthalign, Inc.ONN2024-12-13
00810832032045LanternOrthalign, Inc.ONN2024-12-13
00810832032069LanternOrthalign, Inc.ONN2024-12-13
00810832032076Lantern Orthalign, Inc.ONN2024-12-13
00810832032106Lantern Orthalign, Inc.ONN2024-12-13
00810832032120LanternOrthalign, Inc.ONN2024-12-13
00810832032137LanternOrthalign, Inc.ONN2024-12-13
00810832032144Lantern Surgical AssistantOrthalign, Inc.ONN2024-12-13
00810832032151LanternOrthalign, Inc.ONN2024-12-13
00810832032168LanternOrthalign, Inc.ONN2024-12-13