FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PRESTIGE® Cervical Disc System
DI: 00721902440243
·
Model: 6960015
·
MEDTRONIC SOFAMOR DANEK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRESTIGE® Cervical Disc System
- Primary DI
- 00721902440243
- Version / Model
- 6960015
- Company Name
- MEDTRONIC SOFAMOR DANEK, INC.
- Labeler DUNS
- 830350380
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-23
- Public Version
- 4
- Public Version Date
- 2019-08-30
- Public Version Status
- Update
- Public Device Record Key
- 5eca273e-9a15-4db8-8c73-7ff24eafc869
- Distribution End Date
- 2018-10-08
Device Description
SCREW 6960015 PRSTG BONE FAST 4.0X15MM
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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJO | PROSTHESIS, INTERVERTEBRAL DISC | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61865 | Cervical total disc replacement prosthesis, non-sterile | A non-sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is made of synthetic polymer material(s) [e.g., polyetheretherketone (PEEK)] and typically has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below, to facilitate motion usually through the sliding action of its smooth surfaces. This device is intended to be sterilized before use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00721902440243 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060018 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4.0 | Millimeter | |
| Length | 15.0 | Millimeter |