Duns Number:221751311
Device Description: ANCHORMAN is a cortical tibial ligament fixation device. It consists of a sterile, double ANCHORMAN is a cortical tibial ligament fixation device. It consists of a sterile, double pouched Polyether ether ketone (PEEK) loop with two petals which rest on the cortical bone of the tibia
Catalog Number
-
Brand Name
ANCHORMAN
Version/Model Number
D201019
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 07, 2022
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K170388
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
6c433cdd-0892-4ced-96f9-1bb2aaa138c2
Public Version Date
November 01, 2022
Public Version Number
3
DI Record Publish Date
December 21, 2018
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |