Duns Number:536935331
Device Description: The Advansys Hindfoot Complete set includes TTC plates, screws for fixation, and instrumen The Advansys Hindfoot Complete set includes TTC plates, screws for fixation, and instruments to be used as a guide for the implants, including K-wire. The TTC Plates are intended for arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantation of small bones in the foot and ankle.
Catalog Number
ADVANHIND
Brand Name
Advansys TTC
Version/Model Number
ADVANHIND
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"
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
K022599,K060473,K070160
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
7b870774-4f07-45f0-8b43-0ec6214c021a
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 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 |