Duns Number:139105691
Device Description: HEDRON IC Spacer, 10.5x18, 9mm, 0°
Catalog Number
-
Brand Name
HEDRON
Version/Model Number
1213.8009S
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191243
Product Code
ODP
Product Code Name
Intervertebral fusion device with bone graft, cervical
Public Device Record Key
3abbe7b1-3626-4f86-85d0-69f25bb009f8
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
November 13, 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 | 4975 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34645 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 232 |