STROPP (Single Tunnel Repair of Plantar Plate)
FDA 510(k) K160118 · Crossroads Extremity Systems, LLC
510(k) numberK160118
Submission
- Device name
- STROPP (Single Tunnel Repair of Plantar Plate)
- Applicant
- Crossroads Extremity Systems, LLC
Memphis, TN, US - Received
- January 19, 2016
- Decision date
- May 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K202268 | CrossRoads Tray SystemKCT · Traditional | 12/30/2020SE |
| K190658 | MIS Bunion Plating SystemHRS · Special | 04/12/2019SE |
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| K181866 | MotoCLIP/HiMAX Step Staple Implant SystemJDR · Special | 08/09/2018SE |
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Questions and answers
When was STROPP (Single Tunnel Repair of Plantar Plate) cleared by the FDA?
STROPP (Single Tunnel Repair of Plantar Plate) (K160118) received a 510(k) decision of Substantially Equivalent on May 3, 2016, 105 days after the submission was received.
What is the product code of K160118?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.