BONE PLATE; BONE SCREW— 510(k) K110926
Substantially EquivalentBiomaterials Korea, Inc.
FDA 510(k) clearance K110926 for BONE PLATE; BONE SCREW, Substantially Equivalent on 2011-12-08. Applicant: Biomaterials Korea, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomaterials Korea, 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
- Greenwood Village, CO, 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 Biomaterials Korea, 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.