FDA Registration
Active
🇺🇸 United States
ReUnion
Reg #: 2249697
·
FEI: 3003070421
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- HOWMEDICA OSTEONICS CORP
- Registration Number
- 2249697
- FEI Number
- 3003070421
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 325 CORPORATE DR.
- City
- MAHWAH
- State
- NJ
- ZIP
- 07430
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183039
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 |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2019-02-18 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2019-02-18 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2019-02-18 |
Proprietary Names
ReUnion
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)