Circular Fixation with Balanced Cable Transport
FDA 510(k) K202762 · Smith & Nephew, Inc.
510(k) numberK202762
Submission
- Device name
- Circular Fixation with Balanced Cable Transport
- Applicant
- Smith & Nephew, Inc.
Cordova, TN, US - Received
- September 21, 2020
- Decision date
- November 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
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| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
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Questions and answers
When was Circular Fixation with Balanced Cable Transport cleared by the FDA?
Circular Fixation with Balanced Cable Transport (K202762) received a 510(k) decision of Substantially Equivalent on November 16, 2020, 56 days after the submission was received.
What is the product code of K202762?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.