orthosensor.comVERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
Orthosensor, Inc.
OrthoSensor, Inc.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008592715 | 3008592715 | OrthoSensor, Inc. | 1 | N | 2020-04-25 | 1855 Griffin Road Suite A-310 Dania Beach FL US 33004 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816818021539 | VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 2 | 954-577-7770 | customerservice@orthosensor.com |
| 00816818021546 | VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 3 | 954-577-7770 | customerservice@orthosensor.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 120089 | 1581241714 | K200665 | VERASENSE for Stryker Triathlon | ONN | 2020-04-12 |
| 120089 | 1570258089 | K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | ONN | 2020-04-01 |
| 120089 | 1030122996 | K180459 | VERASENSE for Zimmer Biomet Persona | ONN | 2018-06-07 |
| 120089 | 1158401483 | K150372 | VERASENSE Knee System | ONN | 2016-04-15 |
| 120089 | 1881030855 | ||||
| 120089 | 2066734575 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ONN | 4 | 2020-04-12 |
PMN
VERASENSE For Stryker Triathlon
OrthoSensor, Inc.
VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE For Zimmer Biomet Person
OrthoSensor, Inc.
VERASENSE For Zimmer Biomet Persona
OrthoSensor, Inc.
VERASENSE Knee System
OrthoSensor, Inc.
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
ORTHOSENSOR, INC.
ORTHOSENSOR KNEE BALANCER
ORTHOSENSOR, INC.
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
ORTHOSENSOR, INC.
GUDID
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef
2020-11-18
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig
2020-11-18
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Le
2020-11-18
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Ri
2020-11-18
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Le
2020-11-18
VERASENSE for Zimmer Biomet Persona - VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Ri
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 2
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 3
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 4
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 5
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 6
2020-11-18
VERASENSE for Stryker Triathlon - VERASENSE for Stryker Triathlon CR Size 7
2020-11-18
VERASENSE for Exactech Equinoxe Reverse - VERASENSE for Exactech Equinoxe Reverse Size 38 mm
2020-11-18
VERASENSE for Exactech Equinoxe Reverse - VERASENSE for Exactech Equinoxe Reverse Size 42 mm
2020-11-18
VERASENSE Software Application - 5.6.1.138
2022-08-24
LinkStation MINI - LinkStation MINI with United States and Canada power cord. Bluetooth only
2021-04-28
Linkstation MINI Evaluation Kit - LinkStation MINI Evaluation Kit with power cord for United States and Canada. Bluetooth only.
2021-04-28
VERASENSE - VERASENSE for Smith & Nephew Legion PS size 5-6
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion PS size 7-8
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion CR size 1-2
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion CR size 3-4
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion CR size 5-6
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion CR size 7-8
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion PS size 1-2
2020-12-31
VERASENSE - VERASENSE for Smith & Nephew Legion PS size 3-4
2020-12-31
VERASENSE - VERASENSE for Biomet Vanguard CR size 63/67
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard CR size 71/75
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard CR size 79/83
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard PS size 63/67
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard PS size 71/75
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard PS size 79/83
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 2
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 3
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 4
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 5
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 6
2016-09-23
VERASENSE - VERASENSE for Stryker Triathlon size 7
2016-09-23
VERASENSE - VERASENSE for Biomet Vanguard CR size 63/67
2017-04-21
VERASENSE - VERASENSE for Biomet Vanguard CR size 71/75
2017-04-21
VERASENSE - VERASENSE for Biomet Vanguard CR size 79/83
2017-04-21