CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES— 510(k) K092898
Substantially EquivalentConmed Linvatec
FDA 510(k) clearance K092898 for CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES, Substantially Equivalent on 2009-10-19. Applicant: Conmed Linvatec. Device class: 2.
Clearance details
- Applicant
- Conmed Linvatec
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Largo, FL, US
Recent devices under product code MAI
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view all- K111779 — Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- 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
- K090560 — CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.