FDA UDI
In Commercial Distribution
🇺🇸 United States
CAVUX™ Cervical Cage-L 8x14x17mm
DI: 00852776006355
·
Model: PD-31-611
·
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CAVUX™ Cervical Cage-L 8x14x17mm
- Primary DI
- 00852776006355
- Version / Model
- PD-31-611
- Catalog Number
- PD-31-611
- Company Name
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-28
- Public Version
- 3
- Public Version Date
- 2018-06-22
- Public Version Status
- Update
- Public Device Record Key
- ff94fcd6-7dde-41b0-87bb-3ef6bc15d201
Device Description
CAVUX™ Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX™ Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58109 | Implantable cervical facet joint distractor | A sterile 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852776006352 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00852776006355 | GS1 |