BIOHORIZONS ABUTMENTS FOR ZIMMER— 510(k) K103691
Substantially EquivalentBioHorizons Implant Systems, Inc.
FDA 510(k) clearance K103691 for BIOHORIZONS ABUTMENTS FOR ZIMMER, Substantially Equivalent on 2011-11-03. Applicant: BioHorizons Implant Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- BioHorizons Implant Systems, Inc.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Recent devices under product code NHA
view allMore clearances from BioHorizons Implant Systems, Inc.
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 →
Recalls naming K103691
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103691.
Data sourced from openFDA. This site is unofficial and independent of the FDA.