Duns Number:202981171
Device Description: Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, validators Proximal tibia, disposable instruments (cutting guides, screws, drilling tower, validators)
Catalog Number
015-410-602
Brand Name
Fine Osteotomy disposable instruments - Proximal tibia
Version/Model Number
015-410-602
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
K193614
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
9e2dc9a9-0a86-418c-ab96-7adf7f614b2d
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
May 20, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |