2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445— 510(k) K031981
Substantially EquivalentLinvatec Biomaterials, Ltd.
FDA 510(k) clearance K031981 for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445, Substantially Equivalent on 2003-07-25. Applicant: Linvatec Biomaterials, Ltd.. Device class: 2.
Clearance details
- Applicant
- Linvatec Biomaterials, Ltd.
- 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
view allMore clearances from Linvatec Biomaterials, Ltd.
view all- K042966 — DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
- K042517 — BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
- K042295 — SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
- K032447 — CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
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.