Shoulder Soft Tissue Anchors
FDA 510(k) K242477 · Signature Orthopaedics Pty, Ltd.
510(k) numberK242477
Submission
- Device name
- Shoulder Soft Tissue Anchors
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- August 21, 2024
- Decision date
- May 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Shoulder Soft Tissue Anchors cleared by the FDA?
Shoulder Soft Tissue Anchors (K242477) received a 510(k) decision of Substantially Equivalent on May 12, 2025, 264 days after the submission was received.
What is the product code of K242477?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.