OrthoGold 100
FDA 510(k) clearance K200926 · decided 2020-08-28
Clearance details
- K-number
- K200926
- Device name
- OrthoGold 100
- Applicant
- Tissue Regeneration Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-04-07
- Decision date
- 2020-08-28
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- PZL
- Device class
- 2
- Regulation number
- 878.4685
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woodstock, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.