FDA UDI
In Commercial Distribution
🇺🇸 United States
CAVUX CERVICAL CAGE-X, 5MM
DI: 00852776006447
·
Model: PD-31-204
·
Providence Medical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAVUX CERVICAL CAGE-X, 5MM
- Primary DI
- 00852776006447
- Version / Model
- PD-31-204
- Company Name
- Providence Medical Technology, Inc.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-13
- Public Version
- 2
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- ff0cc818-4cee-4540-845c-78fd59726b72
Device Description
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 Titanium). The implants are single-use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58109 | Implantable cervical facet joint distractor | A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852776006447 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122801 | 000 |