FDA Registration
Active
🇺🇸 United States
G7 MINI TRAY F 110002766
Reg #: 1834030
·
FEI: 1000139824
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ESTES DESIGN AND MFG., INC.
- Registration Number
- 1834030
- FEI Number
- 1000139824
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 470 SOUTH MITTHOEFFER RD.
- City
- Cumberland
- State
- IN
- ZIP
- 46229
- Country
- US
Regulatory Submissions
- 510(k) Number
- K121874
Owner / Operator
- Firm Name
- Estes Design & Manufacturing
- Operator Number
- 9007171
- Address
- 470 SOUTH MITTHOEFFER RD., --
- City
- Indianapolis
- State
- IN
- Postal Code
- 46229
- Country
- US
- Correspondent
- Rich A Kleiman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2021-09-10 |
Proprietary Names
G7 MINI TRAY F 110002766
G7 PRV HD HALF TRY 28/32/36/40 110002768
G7 MINI TRAY A/B 110004130
G7 MINI TRAY FREEDOM B-J 32/36 110018290
G7 MINI TRAY H 110004131
G7 MINI TRAY D 110002764
G7 MINI TRAY C 110002763
G7 MINI TRAY J 110010230
G7 MINI TRAY E 110002765
G7 MINI TRAY RACK 110002770
G7 MINI TRAY I 110004132
G7 PRV HD HALF TRY 32/36/40/44 110004133
G7 MINI TRAY G 110002767
G7 MINI TRAY 110002763
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)