JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
FDA 510(k) clearance K123485 · decided 2013-03-18
Clearance details
- K-number
- K123485
- Device name
- JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF
- Applicant
- Biomet Sports Medicine
- Decision
- Substantially Equivalent
- Date received
- 2012-11-13
- Decision date
- 2013-03-18
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegrad recall (Z-1828-2016) | Biomet, Inc. | 2016-05-26 |
| Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknot recall (Z-0364-2014) | Biomet, Inc. | 2013-11-19 |