Duns Number:536935331
Device Description: The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE al The SOLUSTAPLE is a staple with two self-drilling tips. The treatment with a SOLUSTAPLE allow, after possible treatment of the second ray, to recreate a square or Greek foot. Two types of staples are available (90 or 116 degrees interaxis). In order to safeguard the function of the joint, the staple with oblique design will be used. It is made out of stainless steel, and it is delivered non sterile.
Catalog Number
114023ND
Brand Name
SOLUSTAPLE
Version/Model Number
114023ND
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
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
K991566
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
f545b3c2-1417-47d0-9ee2-d0d163a0defc
Public Version Date
January 27, 2022
Public Version Number
4
DI Record Publish Date
October 09, 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 |