RipCord
FDA 510(k) K251134 · TriMed, Inc.
510(k) numberK251134
Submission
- Device name
- RipCord
- Applicant
- TriMed, Inc.
Santa Clarita, CA, US - Received
- April 11, 2025
- Decision date
- July 11, 2025
- 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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| 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 |
| 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 |
| K250948 | TriMed Fusion Cup SystemHRS · Special | 04/08/2025SE |
Questions and answers
When was RipCord cleared by the FDA?
RipCord (K251134) received a 510(k) decision of Substantially Equivalent on July 11, 2025, 91 days after the submission was received.
What is the product code of K251134?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.