Duns Number:536935331
Device Description: The 2.2mm drilling guide is used to guide the bone drilling and to adjust the orientation The 2.2mm drilling guide is used to guide the bone drilling and to adjust the orientation of the variable angle screws.
Catalog Number
-
Brand Name
CALCANEA™
Version/Model Number
129130ND
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2018
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"
Yes
For Single-Use
-
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
-
Product Code
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
8fe11f7f-ae2d-41f5-9162-b0761256435d
Public Version Date
April 06, 2020
Public Version Number
5
DI Record Publish Date
May 26, 2017
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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |