TRAVERSE™ OCT Spinal Fixation System
GUDID 00613994206374
ROD 7751008EP 5.0X8MM EXT PST BONE SCRW
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994206374 |
| NIH Device Record Key | 67d83c94-a177-4050-9a8c-7c8303cb94f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRAVERSE™ OCT Spinal Fixation System |
| Version Model Number | 7751008EP |
| 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
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994206374 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062447
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
Moist Heat or Steam Sterilization
[00613994206374]
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 | 2015-07-08 |
On-Brand Devices [TRAVERSE™ OCT Spinal Fixation System]
| 00613994207661 | ROD 7751012 5.0X 12MM POSTED BONE SCREW |
| 00613994207654 | ROD 7751010EP 5.0X10MM EXT PST BONE SCRW |
| 00613994207647 | ROD 7751010 5.0X 10MM POSTED BONE SCREW |
| 00613994206374 | ROD 7751008EP 5.0X8MM EXT PST BONE SCRW |
| 00613994205643 | ROD 7750710EP 3.5X10MM EXT PST BONE SCRW |
| 00613994205612 | ROD 7751008 5.0X 8MM POSTED BONE SCREW |
Trademark Results [TRAVERSE]
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