CAVUX™ Cervical Cage SB
GUDID 00852776006423
CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Metallic spinal interbody fusion cage| Primary Device ID | 00852776006423 |
| NIH Device Record Key | a41950ab-c072-443d-8f67-71fc66685330 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CAVUX™ Cervical Cage SB |
| Version Model Number | PD-31-202 |
| Company DUNS | 969820245 |
| Company Name | PROVIDENCE MEDICAL TECHNOLOGY, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852776006423 [Primary] |
| GS1 | 10852776006420 [Package] Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122801
FDA Product Code
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-07-23 |
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 [CAVUX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAVUX 87375477 5271358 Live/Registered |
Providence Medical Technology, Inc. 2017-03-17 |
 CAVUX 86786467 5196437 Live/Registered |
Providence Medical Technology, Inc. 2015-10-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.