CETRA
GUDID 18257200120963
4.5MM X 16MM RESCUE CONSTRAINED SELF-TAPPING SCREW
ORTHOFIX INC.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 18257200120963 |
| NIH Device Record Key | c2a292a0-bab9-4a8d-b6da-8f775be5bdd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CETRA |
| Version Model Number | 19-7016 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200120963 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162638
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
[18257200120963]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
On-Brand Devices [CETRA]
| 18257200140992 | CETRA 2.0 - IMPLANT/INSTRUMENT TRAY KIT (19-1111) |
| 18257200137466 | CETRA - 2.0 BOTTOM TRAY-LEVEL, IMPLANT/INSTRUMENT CASE |
| 18257200137435 | CETRA - 2.0 SCREW CADDY, SEMI-CONSTRAINED SCREWS |
| 18257200137428 | CETRA - 2.0 SCREW CADDY, CONSTRAINED SCREWS |
| 18257200137411 | CETRA - 2.0 IMPLANT/INSTRUMENT CASE |
| 18257200135387 | DOUBLE DRIVER |
| 18257200135202 | 4.5mm X 20mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135196 | 4.5mm X 19mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135189 | 4.5mm X 18mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135172 | 4.5mm X 17mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135165 | 4.5mm X 16mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135158 | 4.5mm X 15mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135141 | 4.5mm X 14mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135134 | 4.5mm X 13mm RESCUE CONSTRAINEDSELF-DRILLING SCREW |
| 18257200135127 | 4.5mm X 12mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135110 | 4.5mm X 11mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135103 | 4.5mm X 10mm RESCUE CONSTRAINED SELF-DRILLING SCREW |
| 18257200135097 | 4.5mm X 20mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135080 | 4.5mm X 19mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135073 | 4.5mm X 18mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135066 | 4.5mm X 17mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135059 | 4.5mm X 16mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135042 | 4.5mm X 15mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135035 | 4.5mm X 14mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135028 | 4.5mm X 13mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135011 | 4.5mm X 12mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200135004 | 4.5mm X 11mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200134991 | 4.5mm X 10mm RESCUE CONSTRAINED SELF-TAPPING SCREW |
| 18257200134984 | 4.0mm X 20mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134977 | 4.0mm X 19mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134960 | 4.0mm X 18mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134953 | 4.0mm X 17mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134946 | 4.0mm X 16mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134939 | 4.0mm X 15mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134922 | 4.0mm X 14mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134915 | 4.0mm X 13mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134908 | 4.0mm X 12mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134892 | 4.0mm X 11mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134885 | 4.0mm X 10mm PRIMARY SEMI-CONSTRAINED SELF-DRILLING SCREW |
| 18257200134878 | 4.0mm X 20mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134861 | 4.0mm X 19mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134854 | 4.0mm X 18mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134847 | 4.0mm X 17mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134830 | 4.0mm X 16mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134823 | 4.0mm X 15mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134816 | 4.0mm X 14mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134809 | 4.0mm X 13mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134793 | 4.0mm X 12mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134786 | 4.0mm X 11mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
| 18257200134779 | 4.0mm X 10mm PRIMARY CONSTRAINED SELF-DRILLING SCREW |
Trademark Results [CETRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CETRA 98157830 not registered Live/Pending |
Kimball International, Inc. 2023-08-30 |
 CETRA 97336417 not registered Live/Pending |
PORTFOLIO CONCENTRATE SOLUTIONS UNLIMITED COMPANY 2022-03-29 |
 CETRA 87019224 5449066 Live/Registered |
Blackstone Medical, Inc. 2016-04-29 |
 CETRA 78164192 2734956 Live/Registered |
CETRA, Inc. 2002-09-14 |
 CETRA 77668642 3727570 Dead/Cancelled |
Kimball International, Inc. 2009-02-11 |
 CETRA 75082847 2047590 Live/Registered |
JACUZZI INC. 1996-04-01 |
 CETRA 74353045 1899443 Dead/Cancelled |
China External Trade Development Council 1993-01-27 |
 CETRA 74308487 1797535 Dead/Cancelled |
Newtec, Inc. 1992-08-28 |
 CETRA 73774879 1564562 Dead/Cancelled |
KIMBALL INTERNATIONAL, INC. 1989-01-17 |
 CETRA 73353493 1264711 Dead/Cancelled |
Cetra 1982-03-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.