Y-KNOT ALL-SUTURE ANCHOR MODEL HF13— 510(k) K111779
Substantially EquivalentConmed Linvatec
FDA 510(k) clearance K111779 for Y-KNOT ALL-SUTURE ANCHOR MODEL HF13, Substantially Equivalent on 2011-08-08. Applicant: Conmed Linvatec. Device class: 2.
Clearance details
- Applicant
- Conmed Linvatec
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code MBI
view allMore clearances from Conmed Linvatec
view all- K102410 — MATRYX INTERFERENCE SCREW (5.0-6.5MM)
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
- K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
- K090560 — CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.