STRETTO Cable System
FDA 510(k) K231333 · Globus Medical, Inc.
510(k) numberK231333
Submission
- Device name
- STRETTO Cable System
- Applicant
- Globus Medical, Inc.
Audubon, PA, US - Received
- May 8, 2023
- Decision date
- August 4, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was STRETTO Cable System cleared by the FDA?
STRETTO Cable System (K231333) received a 510(k) decision of Substantially Equivalent on August 4, 2023, 88 days after the submission was received.
What is the product code of K231333?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.