Duns Number:058864308
Device Description: The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that i The STROPP (Single Tunnel Repair of Plantar Plate) System is a sterile packaged kit that include PEEK implants and related instruments for plantar plate repair. Implants are packaged with the following manual surgical instruments for general use: a needle, needle passer, suture passer, an inserter, K-wires and distractor. The implants are compatible with Size 0 suture; suture is not included with the system. The STROPP System is intended for use with a suture in metatarsal ligament and tendon repairs.
Catalog Number
1601-0000
Brand Name
STRoPP
Version/Model Number
STRoPP Plantar Plate Repair Kit - Sterile
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"
-
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
-
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
0fbe7eda-3125-4cd0-bad7-eae1c9130cb2
Public Version Date
January 08, 2021
Public Version Number
15
DI Record Publish Date
May 10, 2016
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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 713 |