TriMed Ripcord Device
FDA 510(k) K220650 · TriMed, Inc.
510(k) numberK220650
Submission
- Device name
- TriMed Ripcord Device
- Applicant
- TriMed, Inc.
Santa Clarita, CA, US - Received
- March 7, 2022
- Decision date
- June 1, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K251134 | RipCordHTN · Traditional | TriMed, Inc. | 07/11/2025SE |
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More from Vilex, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262344 | Large Compression ScrewsHWC · Special | 08/12/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | 07/16/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | 05/14/2026SE |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S)…HRS · Special | 01/15/2026SE |
| K252061 | Distal Xtremities SystemHRS · Traditional | 08/20/2025SE |
| K251134 | RipCordHTN · Traditional | 07/11/2025SE |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)HRS · Special | 07/10/2025SE |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar…HRS · Traditional | 06/26/2025SE |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…HRS · Traditional | 05/22/2025SE |
| K243943 | TriMed® Compression ScrewsHWC · Traditional | 04/10/2025SE |
Questions and answers
When was TriMed Ripcord Device cleared by the FDA?
TriMed Ripcord Device (K220650) received a 510(k) decision of Substantially Equivalent on June 1, 2022, 86 days after the submission was received.
What is the product code of K220650?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.