FDA Registration
Active
🇺🇸 United States
ALPHAVENT KNOTLESS SP, 4.75MM PEEK, ANCHOR
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STRYKER ENDOSCOPY
- Registration Number
- 2936485
- FEI Number
- 2936485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Optical Ct
- City
- SAN JOSE
- State
- CA
- ZIP
- 95138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233893
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-02-22 |
Proprietary Names
ALPHAVENT KNOTLESS SP, 4.75MM PEEK, ANCHOR
ALPHAVENT KNOTLESS SP, 6.5MM PEEK, ANCHOR
ALPHAVENT KNOTLESS SP, 5.5MM PEEK, ANCHOR
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device