UNIFY
GUDID 00889095189933
4.2mm Variable Angle Screw, Self-Tapping, 24mm
GLOBUS MEDICAL, INC.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00889095189933 |
| NIH Device Record Key | 9e942216-0e4e-4c6e-b3f8-1249c92534c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNIFY |
| Version Model Number | 197.824 |
| Company DUNS | 139105691 |
| Company Name | GLOBUS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com |
Device Dimensions
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 4.2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889095189933 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121049
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
[00889095189933]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2015-11-06 |
On-Brand Devices [UNIFY]
| 00889095190069 | 4.6mm Variable Angle Screw, Self-Tapping, 26mm |
| 00889095190052 | 4.6mm Variable Angle Screw, Self-Tapping, 24mm |
| 00889095190045 | 4.6mm Variable Angle Screw, Self-Tapping, 22mm |
| 00889095190038 | 4.6mm Variable Angle Screw, Self-Tapping, 20mm |
| 00889095190021 | 4.6mm Variable Angle Screw, Self-Tapping, 18mm |
| 00889095190014 | 4.6mm Variable Angle Screw, Self-Tapping, 16mm |
| 00889095190007 | 4.6mm Variable Angle Screw, Self-Tapping, 15mm |
| 00889095189995 | 4.6mm Variable Angle Screw, Self-Tapping, 14mm |
| 00889095189988 | 4.6mm Variable Angle Screw, Self-Tapping, 13mm |
| 00889095189971 | 4.6mm Variable Angle Screw, Self-Tapping, 12mm |
| 00889095189964 | 4.6mm Variable Angle Screw, Self-Tapping, 11mm |
| 00889095189957 | 4.6mm Variable Angle Screw, Self-Tapping, 10mm |
| 00889095189940 | 4.2mm Variable Angle Screw, Self-Tapping, 26mm |
| 00889095189933 | 4.2mm Variable Angle Screw, Self-Tapping, 24mm |
| 00889095189926 | 4.2mm Variable Angle Screw, Self-Tapping, 22mm |
| 00889095189919 | 4.2mm Variable Angle Screw, Self-Tapping, 20mm |
| 00889095189902 | 4.2mm Variable Angle Screw, Self-Tapping, 18mm |
| 00889095189896 | 4.2mm Variable Angle Screw, Self-Tapping, 16mm |
| 00889095189889 | 4.2mm Variable Angle Screw, Self-Tapping, 15mm |
| 00889095189872 | 4.2mm Variable Angle Screw, Self-Tapping, 14mm |
| 00889095189865 | 4.2mm Variable Angle Screw, Self-Tapping, 13mm |
| 00889095189858 | 4.2mm Variable Angle Screw, Self-Tapping, 12mm |
| 00889095189841 | 4.2mm Variable Angle Screw, Self-Tapping, 11mm |
| 00889095189834 | 4.2mm Variable Angle Screw, Self-Tapping, 10mm |
| 00889095189827 | 4.6mm Variable Angle Screw, Self-Drilling, 16mm |
| 00889095189810 | 4.6mm Variable Angle Screw, Self-Drilling, 15mm |
| 00889095189803 | 4.6mm Variable Angle Screw, Self-Drilling, 14mm |
| 00889095189797 | 4.6mm Variable Angle Screw, Self-Drilling, 13mm |
| 00889095189780 | 4.6mm Variable Angle Screw, Self-Drilling, 12mm |
| 00889095189773 | 4.6mm Variable Angle Screw, Self-Drilling, 11mm |
| 00889095189766 | 4.6mm Variable Angle Screw, Self-Drilling, 10mm |
| 00889095189759 | 4.2mm Variable Angle Screw, Self-Drilling, 16mm |
| 00889095189742 | 4.2mm Variable Angle Screw, Self-Drilling, 15mm |
| 00889095189735 | 4.2mm Variable Angle Screw, Self-Drilling, 14mm |
| 00889095189728 | 4.2mm Variable Angle Screw, Self-Drilling, 13mm |
| 00889095189711 | 4.2mm Variable Angle Screw, Self-Drilling, 12mm |
| 00889095189704 | 4.2mm Variable Angle Screw, Self-Drilling, 11mm |
| 00889095189698 | 4.2mm Variable Angle Screw, Self-Drilling, 10mm |
| 00889095189681 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 104mm |
| 00889095189674 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 101mm |
| 00889095189667 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 98mm |
| 00889095189650 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 95mm |
| 00889095189643 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 92mm |
| 00889095189636 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 89mm |
| 00889095189629 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 86mm |
| 00889095189612 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 83mm |
| 00889095189605 | UNIFY Dynamic Anterior Cervical Plate, 5-Level, 80mm |
| 00889095189599 | 4.6mm Fixed Angle Screw, Self-Tapping, 26mm |
| 00889095189582 | 4.6mm Fixed Angle Screw, Self-Tapping, 24mm |
| 00889095189575 | 4.6mm Fixed Angle Screw, Self-Tapping, 22mm |
Trademark Results [UNIFY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNIFY 98788159 not registered Live/Pending |
Science Applications International Corporation 2024-10-07 |
 UNIFY 98527399 not registered Live/Pending |
UNIFY Financial Federal Credit Union 2024-04-30 |
 UNIFY 98210823 not registered Live/Pending |
Rutter Inc. 2023-10-05 |
 UNIFY 98210819 not registered Live/Pending |
Rutter Inc. 2023-10-05 |
 UNIFY 98126849 not registered Live/Pending |
Brahma Vella 2023-08-10 |
 UNIFY 98126842 not registered Live/Pending |
Brahma Vella 2023-08-10 |
 UNIFY 97936814 not registered Live/Pending |
FARO TECHNOLOGIES, INC. 2023-05-15 |
 UNIFY 97652483 not registered Live/Pending |
Red Nucleus Solutions Limited LiabilityCompany 2022-10-28 |
 UNIFY 97288491 not registered Live/Pending |
Nicolas Holdings LLC 2022-02-28 |
 UNIFY 97268714 not registered Live/Pending |
Acoustic, L.P. 2022-02-15 |
 UNIFY 90757623 not registered Live/Pending |
Junbo Huang 2021-06-07 |
 UNIFY 90591639 not registered Live/Pending |
Carlson, Ryan J. 2021-03-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.