Duns Number:772462123
Device Description: NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. http NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Catalog Number
EVONS66070
Brand Name
OTIS-C PLUS
Version/Model Number
NON STERILE Screw for OTIS-C PLUS plate fixation
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2015
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
K120818
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
bc4c6676-1967-4385-8736-d5096dffbd17
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
October 19, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 259 |