JANUS
GUDID 18257200084678
6.5MM X 25MM CORTICAL BONE SCREW
ORTHOFIX INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 18257200084678 |
| NIH Device Record Key | bd0006be-dc18-4559-b843-c24619625f95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JANUS |
| Version Model Number | 36-2625 |
| 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
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200084678 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180179
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
[18257200084678]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-20 |
| Device Publish Date | 2019-03-12 |
On-Brand Devices [JANUS]
| 18257200125777 | TEDAN HANG10 RETRACTOR TRAY KIT (LS-1900) |
| 18257200122295 | TEDAN HANG10 RETRACTOR TRAY KIT (LS-9100) |
| 18257200119721 | MIDLINE SCREW DRIVER |
| 18257200115105 | 7.5MM BONE TAP |
| 18257200115099 | 6.5MM BONE TAP |
| 18257200115082 | 5.5MM BONE TAP |
| 18257200115075 | 4.5MM BONE TAP |
| 18257200112616 | BASE, JANUS INSTRUMENT CASE |
| 18257200112609 | TOP LEVEL TRAY, JANUS INSTRUMENT CASE |
| 18257200112593 | JANUS INSTRUMENT CASE |
| 18257200112517 | JANUS MIDLINE FIXATION IMPLANTS AND INSTRUMENTS (36-7200) |
| 18257200112067 | TEDAN HANG10 RETRACTOR TRAY KIT (LS-9100) |
| 18257200112005 | JANUS CANNULATED SCREW CADDY (36-9200) |
| 18257200111992 | CANNULATED CORTICAL CANCELLOUS SCREW - DOUBLE WIDE MODULAR CANNULATED CADDY |
| 18257200111916 | MIDLINE MODULAR SCREW DRIVER |
| 18257200111909 | DRILL GUIDE |
| 18257200111893 | 7.5MM CANNULATED BONE TAP |
| 18257200111886 | 6.5MM CANNULATED BONE TAP |
| 18257200111879 | 5.5MM CANNULATED BONE TAP |
| 18257200111862 | 4.5MM CANNULATED BONE TAP |
| 18257200111053 | 7.5MM CANNULATED CORTICAL BONE SCREW, 65MM |
| 18257200111046 | 7.5MM CANNULATED CORTICAL BONE SCREW, 60MM |
| 18257200111039 | 7.5MM CANNULATED CORTICAL BONE SCREW, 55MM |
| 18257200111022 | 7.5MM CANNULATED CORTICAL BONE SCREW, 50MM |
| 18257200111015 | 7.5MM CANNULATED CORTICAL BONE SCREW, 45MM |
| 18257200111008 | 7.5MM CANNULATED CORTICAL BONE SCREW, 40MM |
| 18257200110995 | 7.5MM CANNULATED CORTICAL BONE SCREW, 35MM |
| 18257200110988 | 7.5MM CANNULATED CORTICAL BONE SCREW, 30MM |
| 18257200110971 | 7.5MM CANNULATED CORTICAL BONE SCREW, 25MM |
| 18257200110964 | 6.5MM CANNULATED CORTICAL BONE SCREW, 65MM |
| 18257200110957 | 6.5MM CANNULATED CORTICAL BONE SCREW, 60MM |
| 18257200110940 | 6.5MM CANNULATED CORTICAL BONE SCREW, 55MM |
| 18257200110933 | 6.5MM CANNULATED CORTICAL BONE SCREW, 50MM |
| 18257200110926 | 6.5MM CANNULATED CORTICAL BONE SCREW, 45MM |
| 18257200110919 | 6.5MM CANNULATED CORTICAL BONE SCREW, 40MM |
| 18257200110902 | 6.5MM CANNULATED CORTICAL BONE SCREW, 35MM |
| 18257200110896 | 6.5MM CANNULATED CORTICAL BONE SCREW, 30MM |
| 18257200110889 | 6.5MM CANNULATED CORTICAL BONE SCREW, 25MM |
| 18257200110872 | 5.5MM CANNULATED CORTICAL BONE SCREW, 65MM |
| 18257200110865 | 5.5MM CANNULATED CORTICAL BONE SCREW, 60MM |
| 18257200110858 | 5.5MM CANNULATED CORTICAL BONE SCREW, 55MM |
| 18257200110841 | 5.5MM CANNULATED CORTICAL BONE SCREW, 50MM |
| 18257200110834 | 5.5MM CANNULATED CORTICAL BONE SCREW, 45MM |
| 18257200110827 | 5.5MM CANNULATED CORTICAL BONE SCREW, 40MM |
| 18257200110810 | 5.5MM CANNULATED CORTICAL BONE SCREW, 35MM |
| 18257200110803 | 5.5MM CANNULATED CORTICAL BONE SCREW, 30MM |
| 18257200110797 | 5.5MM CANNULATED CORTICAL BONE SCREW, 25MM |
| 18257200110780 | 4.5MM CANNULATED CORTICAL BONE SCREW, 65MM |
| 18257200110773 | 4.5MM CANNULATED CORTICAL BONE SCREW, 60MM |
| 18257200110766 | 4.5MM CANNULATED CORTICAL BONE SCREW, 55MM |
Trademark Results [JANUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JANUS 98746094 not registered Live/Pending |
Business Marketers Group, Inc. 2024-09-11 |
 JANUS 98637342 not registered Live/Pending |
Fr0ntierX Inc. 2024-07-08 |
 JANUS 98496557 not registered Live/Pending |
Paragon Motorcycles Inc. 2024-04-12 |
 JANUS 98256267 not registered Live/Pending |
AltaVoz USA LLC 2023-11-06 |
 JANUS 98248061 not registered Live/Pending |
Rosscor Brands Corp. 2023-10-31 |
 JANUS 97978221 not registered Live/Pending |
J & J GREEN PAPER, INC. 2022-03-30 |
 JANUS 97338214 not registered Live/Pending |
J & J GREEN PAPER, INC. 2022-03-30 |
 JANUS 97008009 not registered Live/Pending |
PerkinElmer Health Sciences, Inc. 2021-09-02 |
 JANUS 90975034 not registered Live/Pending |
Control Technology, Inc. 2020-06-26 |
 JANUS 90696807 not registered Live/Pending |
Janus Health Technologies, Inc. 2021-05-07 |
 JANUS 90621812 not registered Live/Pending |
Roland Anderson 2021-04-02 |
 JANUS 90272234 not registered Live/Pending |
Zhi Yang 2020-10-22 |
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