PRESTIGE® Cervical Disc System
GUDID 00721902440250
SCREW 6960113 PRSTG BONE FAST 4.5X13MM
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system| Primary Device ID | 00721902440250 |
| NIH Device Record Key | 2c48693a-4885-4a74-85aa-2407723230fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRESTIGE® Cervical Disc System |
| Version Model Number | 6960113 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | false |
| 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 Dimensions
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
| Length | 13 Millimeter |
| Width | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902440250 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P060018
FDA Product Code
| MJO | PROSTHESIS, INTERVERTEBRAL DISC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
[00721902440250]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [PRESTIGE® Cervical Disc System]
| 00613994237064 | TRIAL 6972226 IMPLANT TRIAL 6X12 |
| 00613994237040 | TRIAL 6972246 IMPLANT TRIAL 6X14 |
| 00613994237033 | TRIAL 6972247 IMPLANT TRIAL 7X14 |
| 00613994237019 | TRIAL 6972266 IMPLANT TRIAL 6X16 |
| 00613994237002 | TRIAL 6972267 IMPLANT TRIAL 7X16 |
| 00613994236982 | TRIAL 6972287 IMPLANT TRIAL 7X18 |
| 00613994129253 | DISC 6961870 CERVICAL DISC 7MM X 18MM |
| 00613994129239 | DISC 6961670 CERVICAL DISC 7MM X 16MM |
| 00613994129222 | DISC 6961660 CERVICAL DISC 6MM X 16MM |
| 00613994129215 | DISC 6961460 CERVICAL DISC 6MM X 14MM |
| 00721902723254 | DISC 6961470 PRESTIGE ARTIFICIAL 7X14MM |
| 00721902723223 | PRESTIGE ARTIFICIAL DISC 6X12MM |
| 00721902451959 | SCREW 6960120 LOCK |
| 00721902440250 | SCREW 6960113 PRSTG BONE FAST 4.5X13MM |
| 00721902440243 | SCREW 6960015 PRSTG BONE FAST 4.0X15MM |
| 00721902440236 | SCREW 6960013 PRSTG BON FAST 4.0X13MM |
Trademark Results [PRESTIGE]
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