FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OrthoGold 100
K Number: K200926
·
Decision Aug 28, 2020
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
7
Applicant Total
2
Review Days
143
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Basic Information
- Device Name
- OrthoGold 100
- K Number
- K200926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4685
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tissue Regeneration Technologies, LLC
- Date Received
- April 7, 2020
- Decision Date
- August 28, 2020
- Product Code
- PZL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Tissue Regeneration Technologies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K210451 | OrthoGold 100 | May 5, 2021 | Substantially Equivalent |