UNITY
GUDID 18257200032594
SCREW, 1/4-28 LOCKING ANTERIOR LUMBAR SYSTEM NEW P/N 90-1481
ORTHOFIX INC.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 18257200032594 |
| NIH Device Record Key | 50bdfe19-8eba-438c-9691-87d3d17f4742 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UNITY |
| Version Model Number | 43-6001 |
| 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 | false |
| 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 | 18257200032594 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061229
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
Moist Heat or Steam Sterilization
[18257200032594]
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 [UNITY]
| 18257200081134 | UNITY LX LUMBOSACRAL FIXATION SYSTEM (43-0020) |
| 18257200081127 | UNITY LUMBOSACRAL FIXATION SYSTEM (43-0010) |
| 18257200032594 | SCREW, 1/4-28 LOCKING ANTERIOR LUMBAR SYSTEM NEW P/N 90-1481 |
| 18257200032563 | UNITY TORQUE WRENCH 50/IN LBS |
| 18257200032556 | DRILL POWER UNITY ANTERIOR LUMBAR SYSTEM |
| 18257200032549 | HEX DRIVER, SOLID SHORT ANTERIOR LUMBAR PLATE |
| 18257200032532 | HEX DRIVER, SOLID LONG ANTERIOR LUMBAR PLATE |
| 18257200032525 | COVER PLATE DRIVER - SOLID ANTERIOR LUMBAR PLATE |
| 18257200032518 | HEX DRIVER, 3.5MM SPLIT SHORT ANTERIOR LUMBAR SYSTEM |
| 18257200032501 | BONE AWL, ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032495 | BONE PROBE, ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032488 | TAP, 6.0MM ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032471 | DRILL, MODULAR ANTERIOR LUMBAR SYSTEM |
| 18257200032464 | FIXED GUIDE ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032457 | FIXED FREEHAND GUIDE ANTERIOR LUMBAR PLATE |
| 18257200032440 | TACK ANTERIOR LUMBAR PLATE |
| 18257200032433 | TACK HOLDER ANTERIOR LUMBAR SYSTEM |
| 18257200032426 | HEX DRIVER, 3.5MM SOLID LONG ANTERIOR LUMBAR SYSTEM |
| 18257200032419 | HEX DRIVER, 3.5MM SPLIT LONG ANTERIOR LUMBAR SYSTEM |
| 18257200032402 | COVER HOLDER ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032396 | COVER HOLDER ASSEMBLY ANTERIOR LUMBAR PLATE |
| 18257200032389 | PLATE HOLDER ASSEMBLY, SHORT ANTERIOR LUMBAR PLATE |
| 18257200032372 | PLATE HOLDER ASSEMBLY, LONG ANTERIOR LUMBAR PLATE |
| 18257200009688 | 7.0mm X 35mm Rescue Screw |
| 18257200009671 | 7.0mm X 30mm Rescue Screw |
| 18257200009664 | 7.0mm X 25mm Rescue Screw |
| 18257200009657 | 6.0mm X 35mm Bone Screw |
| 18257200009640 | 6.0mm X 30mm Bone Screw |
| 18257200009633 | 6.0mm X 25mm Bone Screw |
| 18257200009626 | 31mm Plate Cover |
| 18257200009619 | 28mm Plate Cover |
| 18257200009602 | 25mm Plate Cover |
| 18257200009596 | 23mm Plate Cover |
| 18257200009589 | 21mm Plate Cover |
| 18257200009572 | 19mm Plate Cover |
| 18257200009565 | 31mm Lumbar Plate |
| 18257200009558 | 28mm Lumbar Plate |
| 18257200009541 | 25mm Lumbar Plate |
| 18257200009534 | 23mm Lumbar Plate |
| 18257200009527 | 21mm Lumbar Plate |
| 18257200009510 | 19mm Lumbar Plate |
| 18257200009503 | 28mm Plate Cover |
| 18257200009497 | 25mm Plate Cover |
| 18257200009480 | 23mm Plate Cover |
| 18257200009473 | 21mm Plate Cover |
| 18257200009466 | 19mm Plate Cover |
| 18257200009459 | 17mm Plate Cover |
| 18257200009442 | 28mm Lumbar Plate |
| 18257200009435 | 25mm Lumbar Plate |
| 18257200009428 | 23mm Lumbar Plate |
Trademark Results [UNITY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNITY 98629505 not registered Live/Pending |
Unity Surveillance Inc. 2024-07-02 |
 UNITY 98579661 not registered Live/Pending |
Unity LLC 2024-05-31 |
 UNITY 98490596 not registered Live/Pending |
4Movie B.V. 2024-04-09 |
 UNITY 98468012 not registered Live/Pending |
I.D. Systems, Inc. 2024-03-26 |
 UNITY 98448298 not registered Live/Pending |
Fold Health, Inc. 2024-03-13 |
 UNITY 98400951 not registered Live/Pending |
Golden Sherpa LLC 2024-02-10 |
 UNITY 98368672 not registered Live/Pending |
David Yurman IP LLC 2024-01-22 |
 UNITY 98250194 not registered Live/Pending |
SN Space Systems LLC 2023-11-01 |
 UNITY 97874038 not registered Live/Pending |
Karp, Randy Y. 2023-04-05 |
 UNITY 97857977 not registered Live/Pending |
Alcon Inc. 2023-03-27 |
 UNITY 97827259 not registered Live/Pending |
BRAND FELT OF CANADA LTD. 2023-03-07 |
 UNITY 97812375 not registered Live/Pending |
Foster, Anthony 2023-02-26 |
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