BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS— 510(k) K042517
Substantially EquivalentLinvatec Biomaterials, Ltd.
FDA 510(k) clearance K042517 for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS, Substantially Equivalent on 2004-10-08. Applicant: Linvatec Biomaterials, Ltd.. Device class: 2.
Clearance details
- Applicant
- Linvatec Biomaterials, Ltd.
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tampere, FI
Recent devices under product code JEY
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- K252246 — Leforte MMF System
- K253373 — Southern Craniomaxillofacial (CMF) System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
More clearances from Linvatec Biomaterials, Ltd.
view all- K042966 — DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
- K042295 — SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
- K032447 — CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
- K031981 — 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.