FDA Registration
Inactive
🇺🇸 United States
ATOMIC Nitinol Fixation System
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLAZE BIOTECH, LLC
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4600 Lockhill Selma Rd Ste 107
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232990
Owner / Operator
- Firm Name
- Blaze Biotech, LLC
- Operator Number
- 10093736
- Address
- 4600 Lockhill Selma Rd. Ste. 107
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- Monica Lesch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-06-30 |
Proprietary Names
ATOMIC Nitinol Fixation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)