Duns Number:536935331
Device Description: The principal of the FOREFOOT sets is to propose a group of implants (screws and staples) The principal of the FOREFOOT sets is to propose a group of implants (screws and staples) and the associated instruments in a single package dedicated to the forefoot orthopaedic surgery. The set is intended to make easy the surgeon work and give more solution in the same set. The Forefoot Set includes Bold compression screws, QWIX fixation screws, Spin snap-off screws, Solustaple, Uni-clip staples, and instrumentation.
Catalog Number
FFINSTSET
Brand Name
Forefoot
Version/Model Number
FFINSTSET
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
K011262,K011716,K022599,K990622,K991477,K991482
Product Code
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
c33f8248-beed-49f1-ad30-210515bd0227
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 |