Duns Number:927083808
Device Description: CONSTRUX MINI 10MM H X 15MM W X 12MM L - 5DEG LORDOTIC
Catalog Number
-
Brand Name
CONSTRUX - MINI PEEK VBR
Version/Model Number
47-4010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172437
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
7c0be448-9800-4d04-b8ba-a74b000dbd56
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
March 19, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2497 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5891 |
| 3 | A medical device with high risk that requires premarket approval | 104 |