Primary Device ID | 18257200009510 |
NIH Device Record Key | 6d5f097a-4f56-44fd-a30d-de77f8ac0858 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UNITY |
Version Model Number | 43-3019 |
Company DUNS | 927083808 |
Company Name | ORTHOFIX INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Length | 28 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 18257200009510 [Primary] |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
[18257200009510]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-08-01 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
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Unity Surveillance Inc. 2024-07-02 |
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Unity LLC 2024-05-31 |
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4Movie B.V. 2024-04-09 |
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I.D. Systems, Inc. 2024-03-26 |
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Fold Health, Inc. 2024-03-13 |
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Golden Sherpa LLC 2024-02-10 |
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David Yurman IP LLC 2024-01-22 |
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SN Space Systems LLC 2023-11-01 |
![]() UNITY 97874038 not registered Live/Pending |
Karp, Randy Y. 2023-04-05 |
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Alcon Inc. 2023-03-27 |
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BRAND FELT OF CANADA LTD. 2023-03-07 |
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Foster, Anthony 2023-02-26 |