FDA Registration
Active
🇺🇸 United States
11cm iQ Knife
Reg #: 3015967359
·
FEI: 3015967359
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Stryker Instruments
- Registration Number
- 3015967359
- FEI Number
- 3015967359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1941 Stryker Way
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213824
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 |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2022-02-17 |
Proprietary Names
11cm iQ Knife
18cm iQ Apex Micro Claw
12cm iQ Large
11cm iQ Apex Knife
20cm iQ Apex 360
10cm iQ Broad Knife
18cm iQ Micro Claw
12cm iQ Apex 360
SONOPET IQ CONSOLE
12cm iQ Barracuda
12cm iQ Standard
12cm iQ Serrated Large
20cm iQ Standard
12cm iQ Claw
12cm iQ Micro Claw
12cm iQ Micro
12cm iQ 120 Claw
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198