FOCUS
GUDID 00814008027446
Rod, Straight 5.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00814008027446 |
| NIH Device Record Key | f5891525-d2fd-4ea0-93cc-42a6286b5a1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FOCUS |
| Version Model Number | S-01-045 |
| Company DUNS | 047486041 |
| Company Name | NVISION BIOMEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com | |
| Phone | 210-545-3713 |
| Diana@nvisionbiomed.com |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
| Special Storage Condition, Specify | Between 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814008027446 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180458
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
[00814008027446]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2018-12-15 |
On-Brand Devices [FOCUS]
| 00814008029822 | Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029815 | Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervic |
| 00814008029754 | Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cer |
| 00814008029747 | Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior |
| 00814008029730 | Rod, MIS, Lordotic 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cer |
| 00814008029723 | Rod, MIS, Lordotic 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cer |
| 00814008029716 | Rod, MIS, Lordotic 5.5X110mm. The FOCUS Pedicle Screw System is intended for use in the non-cer |
| 00814008029709 | Rod, MIS, Lordotic 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cer |
| 00814008029693 | Rod, MIS, Lordotic 5.5X90mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029686 | Rod, MIS, Lordotic 5.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029679 | Rod, MIS, Lordotic 5.5X70mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029662 | Rod, MIS, Lordotic 5.5X65mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029655 | Rod, MIS, Lordotic 5.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029648 | Rod, MIS, Lordotic 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029631 | Rod, MIS, Lordotic 5.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029624 | Rod, MIS, Lordotic 5.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029617 | Rod, MIS, Lordotic 5.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029600 | Rod, MIS, Lordotic 5.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029594 | Rod, MIS, Lordotic 5.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv |
| 00814008029587 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X110mm. The FOCUS Pedicle Screw System is inte |
| 00814008029570 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X105mm. The FOCUS Pedicle Screw System is inte |
| 00814008029563 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is inte |
| 00814008029556 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X95mm. The FOCUS Pedicle Screw System is inten |
| 00814008029549 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X90mm. The FOCUS Pedicle Screw System is inten |
| 00814008029532 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X85mm. The FOCUS Pedicle Screw System is inten |
| 00814008029525 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X80mm. The FOCUS Pedicle Screw System is inten |
| 00814008029518 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X75mm. The FOCUS Pedicle Screw System is inten |
| 00814008029501 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X70mm. The FOCUS Pedicle Screw System is inten |
| 00814008029495 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X65mm. The FOCUS Pedicle Screw System is inten |
| 00814008029488 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X60mm. The FOCUS Pedicle Screw System is inten |
| 00814008029471 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X55mm. The FOCUS Pedicle Screw System is inten |
| 00814008029464 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X50mm. The FOCUS Pedicle Screw System is inten |
| 00814008029457 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X45mm. The FOCUS Pedicle Screw System is inten |
| 00814008029440 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X40mm. The FOCUS Pedicle Screw System is inten |
| 00814008029433 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X35mm. The FOCUS Pedicle Screw System is inten |
| 00814008029426 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X30mm. The FOCUS Pedicle Screw System is inten |
| 00814008029419 | PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X25mm. The FOCUS Pedicle Screw System is inten |
| 00814008029402 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X60mm. The FOCUS Pedicle Screw System is inten |
| 00814008029396 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X55mm. The FOCUS Pedicle Screw System is inten |
| 00814008029389 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X50mm. The FOCUS Pedicle Screw System is inten |
| 00814008029372 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X45mm. The FOCUS Pedicle Screw System is inten |
| 00814008029365 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X40mm. The FOCUS Pedicle Screw System is inten |
| 00814008029358 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X35mm. The FOCUS Pedicle Screw System is inten |
| 00814008029341 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X30mm. The FOCUS Pedicle Screw System is inten |
| 00814008029334 | PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X25mm. The FOCUS Pedicle Screw System is inten |
| 00814008029327 | PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X60mm. The FOCUS Pedicle Screw System is inten |
| 00814008029310 | PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X55mm. The FOCUS Pedicle Screw System is inten |
| 00814008029303 | PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X50mm. The FOCUS Pedicle Screw System is inten |
| 00814008029297 | PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X45mm. The FOCUS Pedicle Screw System is inten |
| 00814008029280 | PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X40mm. The FOCUS Pedicle Screw System is inten |
Trademark Results [FOCUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOCUS 98602109 not registered Live/Pending |
International IP Holdings, LLC 2024-06-14 |
 FOCUS 98340160 not registered Live/Pending |
QBCure, LLC 2024-01-03 |
 FOCUS 98227197 not registered Live/Pending |
Focus Labs 2023-10-17 |
 FOCUS 98188568 not registered Live/Pending |
Morning View Nutrition LLC 2023-09-20 |
 FOCUS 98182951 not registered Live/Pending |
Offset Consulting LLC 2023-09-15 |
 FOCUS 98105716 not registered Live/Pending |
LF Projects, LLC 2023-07-27 |
 FOCUS 98015795 not registered Live/Pending |
Elite Gold Ltd. 2023-05-26 |
 FOCUS 97888641 not registered Live/Pending |
Seachem Laboratories, Inc. 2023-04-14 |
 FOCUS 97749339 not registered Live/Pending |
Aderis Energy, LLC 2023-01-11 |
 FOCUS 97730674 not registered Live/Pending |
A-G Associates, Inc. 2022-12-23 |
 FOCUS 97594820 not registered Live/Pending |
Firstgroup America, Inc. 2022-09-16 |
 FOCUS 97566994 not registered Live/Pending |
Access eforms, LP 2022-08-26 |
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