FDA UDI
In Commercial Distribution
🇺🇸 United States
PRESTIGE® Cervical Disc System
DI: 00613994129239
·
Model: 6961670
·
MEDTRONIC SOFAMOR DANEK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PRESTIGE® Cervical Disc System
- Primary DI
- 00613994129239
- Version / Model
- 6961670
- Company Name
- MEDTRONIC SOFAMOR DANEK, INC.
- Labeler DUNS
- 830350380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 6
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 91ddb169-6813-419f-a55a-048c855a66d1
Device Description
DISC 6961670 CERVICAL DISC 7MM X 16MM
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJO | PROSTHESIS, INTERVERTEBRAL DISC | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48164 | Cervical total intervertebral disc prosthesis, modular | An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994129239 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060018 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7.0 | Millimeter | |
| Depth | 16.0 | Millimeter |