FDA Registration
Active
🇺🇸 United States
OPERON Accessories
Reg #: 2031963
·
FEI: 3002975342
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER Communications, Inc.
- Registration Number
- 2031963
- FEI Number
- 3002975342
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 571 Silveron Blvd.
- City
- Flower Mound
- State
- TX
- ZIP
- 75028
- Country
- US
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 |
|---|---|---|---|---|---|
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2014-12-18 |
Proprietary Names
OPERON Accessories
K-TEK SWIVEL ARMBOARD, LARGE
K-TEK CLAMSHELL ARMBOARD PAD 3"
K-TEK ARMBOARD, US
K-TEK LATERAL POSITIONER, ROUND
K-TEK LATERAL POSITIONER, RECTANGLE
K-TEK COMFORT STANDARD ARMBOARD PAD, 2 3/8
K-TEK CURVE CRANK HANDLE
K-TEK SWIVEL ARMBOARD, SMALL
K-TEK CURVE SPINE FRAME
Establishment Types
Complaint File Establishment per 21 CFR 820.198