Duns Number:202981171
Device Description: Tibial plate, Cortical Compression Screws, cancellous Compression Screws and disposable in Tibial plate, Cortical Compression Screws, cancellous Compression Screws and disposable instrumentation
Catalog Number
015-410-001
Brand Name
Fine Osteotomy system - Proximal tibia
Version/Model Number
015-410-001
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
K211646
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
ea73037f-e3cb-4893-b021-d11e8b5d76f2
Public Version Date
December 07, 2021
Public Version Number
1
DI Record Publish Date
November 29, 2021
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 |