OrthoGold 100— 510(k) K182682
Substantially EquivalentTissue Regeneration Technologies
FDA 510(k) clearance K182682 for OrthoGold 100, Substantially Equivalent on 2018-12-21. Applicant: Tissue Regeneration Technologies.
Clearance details
- Applicant
- Tissue Regeneration Technologies
- Product code
- Code ISA
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodstock, GA, US
Adverse events under product code ISA
product code ISA- Death
- 3
- Other
- 1
- Total
- 4
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.