FDA Registration
Active
🇺🇸 United States
Ascent Flexx PRP
Reg #: 3032542289
·
FEI: 3032542289
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORTHOASCENT LLC
- Registration Number
- 3032542289
- FEI Number
- 3032542289
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9035 Wadsworth Pkwy Ste 1000
- City
- Westminster
- State
- CO
- ZIP
- 80021
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK241083
Owner / Operator
- Firm Name
- OrthoAscent LLC
- Operator Number
- 10091190
- Address
- 9035 Wadsworth Pkwy #1000
- City
- Westminster
- State
- CO
- Postal Code
- 80021
- Country
- US
- Correspondent
- Mike A Masters
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2024-09-30 |
Proprietary Names
Ascent Flexx PRP
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility