JuggerKnot Soft Anchors
FDA 510(k) K150768 · Biomet Manufacturing Corp
510(k) numberK150768
Submission
- Device name
- JuggerKnot Soft Anchors
- Applicant
- Biomet Manufacturing Corp
Warsaw, IL, US - Received
- March 24, 2015
- Decision date
- September 4, 2015
- 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 JuggerKnot Soft Anchors cleared by the FDA?
JuggerKnot Soft Anchors (K150768) received a 510(k) decision of Substantially Equivalent on September 4, 2015, 164 days after the submission was received.
What is the product code of K150768?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.