FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS— 510(k) K091812
Substantially EquivalentFrontier Devices, Inc.
FDA 510(k) clearance K091812 for FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS, Substantially Equivalent on 2010-05-07. Applicant: Frontier Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Frontier Devices, 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
- Traditional
- Location
- Pelham, AL, 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
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.