BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES— 510(k) K003756
Substantially EquivalentBionx Implants, Inc.
FDA 510(k) clearance K003756 for BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES, Substantially Equivalent on 2001-01-03. Applicant: Bionx Implants, Inc.. Device class: 2.
Clearance details
- Applicant
- Bionx Implants, Inc.
- 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
- Blue Bell, PA, US
Recent devices under product code JEY
view all- K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more
- K253206 — METICULY Patient-specific CMF solution
- 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 Bionx Implants, Inc.
view allAdverse 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.