TENSOR® Suture Button System
FDA 510(k) K240947 · Globus Medical, Inc.
510(k) numberK240947
Submission
- Device name
- TENSOR® Suture Button System
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- April 8, 2024
- Decision date
- June 3, 2024
- 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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Questions and answers
When was TENSOR® Suture Button System cleared by the FDA?
TENSOR® Suture Button System (K240947) received a 510(k) decision of Substantially Equivalent on June 3, 2024, 56 days after the submission was received.
What is the product code of K240947?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.