FDA.reportPublic FDA data

LinkStation MINI Evaluation Kit

Primary DI
00816818020549
Brand
LinkStation MINI Evaluation Kit
Company
ORTHOSENSOR INC
Model
LinkStation MINI Evaluation Kit
Catalog number
05000-505
Device description
LinkStation MINI Evaluation Kit with Italy power cord
Published
2017-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K150372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150372000VERASENSE Knee SystemOrthosensor, Inc.2016-04-15ONN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816818020549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816818020549008168180205498168180205490816818020549

GMDN Terms#

Term, Definition table
TermDefinition
Arthroplasty force sensor display unitA electrically-powered electronic device designed to wirelessly connect to an arthroplasty force sensor to display readings from the sensor to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It consists of a computing device with installed dedicated application software, which may have a dedicated receiver.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005788130
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816818021478VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR C-D/3-9 LefZBH-PSNCRCD39-L2020-11-18
00816818021485VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR C-D/3-9 RigZBH-PSNCRCD39-R2020-11-18
00816818021492VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR E-F/3-11 LeZBH-PSNCREF311-L2020-11-18
00816818021508VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR E-F/3-11 RiZBH-PSNCREF311-R2020-11-18
00816818021515VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeZBH-PSNCRGH712-L2020-11-18
00816818021522VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR G-H/7-12 RiZBH-PSNCRGH712-R2020-11-18
00816818020372VERASENSE HandleVERASENSE Handle03000-5012016-09-23
00816818020396VERASENSEVERASENSE for Zimmer NexGen CR C-H/5-6ZMR-NGCRCH562016-11-18
00816818020402VERASENSEVERASENSE for Zimmer NexGen CR C-H/7-10ZMR-NGCRCH702016-11-18
00816818020419VERASENSEVERASENSE for Zimmer NexGen PS C-D/3-4ZMR-NGPSCD342016-11-18
00816818020426VERASENSEVERASENSE for Zimmer NexGen PS E-F/3-4ZMR-NGPSEF342016-11-18
00816818020433VERASENSEVERASENSE for Zimmer NexGen PS E-F/5-6ZMR-NGPSEF562016-11-18
00816818020440LinkStation MINILinkStation MINI05000-0012017-05-02
00816818020457LinkStation MINILinkStation MINI05000-0022017-02-20
00816818020464LinkStation MINILinkStation MINI05000-0032017-02-20
00816818020471LinkStation MINI LinkStation MINI 05000-0042017-02-20
00816818020488LinkStation MINILinkStation MINI05000-0052017-02-20
00816818020495LinkStation MINILinkStation MINI05000-0062017-02-20
00816818020501Linkstation MINI Evaluation KitLinkstation MINI Evaluation Kit05000-5002017-02-20
00816818020518LinkStation MINI Evaluation KitLinkStation MINI Evaluation Kit05000-5022017-02-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00810832032199LanternOrthalign, Inc.ONN2024-12-13