FDA.reportPublic FDA data

VERASENSE for Stryker Triathlon

Primary DI
00816818021546
Brand
VERASENSE for Stryker Triathlon
Company
ORTHOSENSOR INC
Model
VERASENSE for Stryker Triathlon CR Size 3
Catalog number
SYK-TRCR03
Published
2020-11-18
Public version status
Update
Distribution status
Not 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
ONNIntraoperative Orthopedic Joint Assessment Aid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200665000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200665000VERASENSE for Stryker TriathlonOrthosensor, Inc.2020-04-12ONN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816818021546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816818021546008168180215468168180215460816818021546

GMDN Terms#

Term, Definition table
TermDefinition
Arthroplasty force sensorAn electronic device designed for use during arthroplasty to facilitate assessment of joint function during implantation of prosthesis components, typically to evaluate bone resection lines, prosthesis size and positioning, and/or soft tissue tension. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or communicate with an external display unit; some types include a noninvasive analogue-to-digital converter and image display controller. It is typically available as a left or right version. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-577-7770customerservice@orthosensor.com

Regulatory Flags#

DUNS number
005788130
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
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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