DTRAX® Spinal System-L DX-22-600
GUDID 10852776006185
A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver.
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Internal spinal fixation procedure kit, single-use| Primary Device ID | 10852776006185 |
| NIH Device Record Key | f78fb550-ed1f-4522-a5d7-ff1ee90af710 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTRAX® Spinal System-L |
| Version Model Number | DX-22-600 |
| Catalog Number | DX-22-600 |
| Company DUNS | 969820245 |
| Company Name | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852776006188 [Primary] |
| GS1 | 10852776006185 [Package] Contains: 00852776006188 Package: Box [1 Units] In Commercial Distribution |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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[10852776006185]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-10-12 |
Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.
| 00852776006447 - CAVUX CERVICAL CAGE-X, 5MM | 2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac |
| 00852776006553 - ALLY Bone Screw-LX | 2024-11-21 The ALLY Bone Screw-LX is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fr |
| 00852776006560 - CAVUX Cage-LX, 4mm | 2024-11-21 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine |
| 00852776006584 - CORUS Spinal System-LX | 2024-11-21 CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bon |
| 00852776006591 - CAVUX Facet Fixation System, 4mm | 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX |
| 00852776006607 - CAVUX Facet Fixation System, 5mm | 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX |
| 00852776006638 - CORUS Navigation Access System | 2024-11-21 The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal Sys |
| 00852776006492 - CAVUX Cervical Cage-X | 2024-11-01 |
Trademark Results [DTRAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DTRAX 87939439 not registered Live/Pending |
Deloitte LLP 2018-05-29 |
 DTRAX 87375466 5322967 Live/Registered |
Providence Medical Technology, Inc. 2017-03-17 |
 DTRAX 85115258 4176247 Live/Registered |
Providence Medical Technology, Inc. 2010-08-25 |
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