CyclaPlex Correction System
FDA 510(k) K183094 · Cycla Orthopedics, Ltd.
510(k) numberK183094
Submission
- Device name
- CyclaPlex Correction System
- Applicant
- Cycla Orthopedics, Ltd.
Bat Shlomo, IL - Received
- November 7, 2018
- Decision date
- April 26, 2019
- 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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| K253115 | Lars AcjHTN · Traditional | Movmedix S.A.S. | 06/10/2026SE |
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| K243624 | Acu-Sinch Knotless MiniHTN · Traditional | Acumed, LLC | 01/23/2025SE |
| K242091 | Bolo Button SystemHTN · Traditional | Fusion Orthopedics | 12/23/2024SE |
| K243408 | TACTIX Vector Syndesmosis SystemHTN · Special | Vilex, LLC | 11/27/2024SE |
| K242311 | EXPERT - Flexible Joint Fixation SystemHTN · Traditional | GM Dos Reis Industria e Comercio Ltda. | 11/01/2024SE |
| K240035 | TACTIX Vector Syndesmosis SystemHTN · Traditional | Vilex, LLC | 08/01/2024SE |
Questions and answers
When was CyclaPlex Correction System cleared by the FDA?
CyclaPlex Correction System (K183094) received a 510(k) decision of Substantially Equivalent on April 26, 2019, 170 days after the submission was received.
What is the product code of K183094?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.