VENTURE™ Anterior Cervical Plate System
GUDID 00613994143297
PLATE X1205094 VEN SCR ST FA 4.0X16
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994143297 |
| NIH Device Record Key | 4c633b06-8f44-43fe-a3f1-e6afd9934fcb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTURE™ Anterior Cervical Plate System |
| Version Model Number | X1205094 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994143297 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042922
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
Moist Heat or Steam Sterilization
[00613994143297]
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 | 2015-07-10 |
On-Brand Devices [VENTURE™ Anterior Cervical Plate System]
| 00613994143372 | PLATE X1205102 VEN SCR ST VA 4.0X20 |
| 00613994143365 | PLATE X1205101 VEN SCR ST VA 4.0X18 |
| 00613994143358 | PLATE X1205100 VEN SCR ST VA 4.0X16 |
| 00613994143341 | PLATE X1205099 VEN SCR ST VA 4.0X14 |
| 00613994143310 | PLATE X1205096 VEN SCR ST FA 4.0X20 |
| 00613994143303 | PLATE X1205095 VEN SCR ST FA 4.0X18 |
| 00613994143297 | PLATE X1205094 VEN SCR ST FA 4.0X16 |
| 00613994143280 | PLATE X1205093 VEN SCR ST FA 4.0X14 |
| 00613994143273 | PLATE X1205092 VEN SCR ST FA 4.0X12 |
Trademark Results [VENTURE]
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