Duns Number:328420633
Device Description: Cancellous Screw 4.0, small head, T15, full thread, L 75 Titanium
Catalog Number
SP 4035-75-2
Brand Name
NA
Version/Model Number
SP 4035-75-2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182818
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
7997ad3d-a8d2-488d-86d6-d4ced1bac17a
Public Version Date
April 03, 2020
Public Version Number
1
DI Record Publish Date
March 26, 2020
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 | 738 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2701 |