SYNTHES 1.3 MM SELF-DRILLING SCREW— 510(k) K983485
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K983485 for SYNTHES 1.3 MM SELF-DRILLING SCREW, Substantially Equivalent on 1998-12-21. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code DZL
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- K120717 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
Adverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
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.