FDA Registration
Active
🇺🇸 United States
Hinged Knee w/Covered Hinge, Hinged Lateral Patella Stabilizer
Reg #: 3003890514
·
FEI: 3003890514
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- TOP SHELF MANUFACTURING, LLC
- Registration Number
- 3003890514
- FEI Number
- 3003890514
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1851 E. PARADISE ROAD, SUITE A
- City
- Tracy
- State
- CA
- ZIP
- 95304
- Country
- US
Owner / Operator
- Firm Name
- TOP SHELF MANUFACTURING, LLC
- Operator Number
- 9054233
- Address
- 1851 E. PARADISE RD, SUITE A, --
- City
- Tracy
- State
- CA
- Postal Code
- 95304
- Country
- US
- Correspondent
- CRAIG - KOLOSKE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2002-12-10 |
Proprietary Names
Hinged Knee w/Covered Hinge, Hinged Lateral Patella Stabilizer
RelOAd Knee Brace, Lateral Patella Stabilizer, Tri-Panel Knee Immobilizer, Knee Immobilizer, Protex Elbow Brace
Elbow ROM Post-Op Brace, Target OA Knee Brace
Lateral Patella Stabilizer w/Contour Hinge, Hinged Knee Plus Half Wrap, The Crusader, Knight Lite
Hinged Knee Plus, Hinged Knee, Revolution Knee Brace, The Knight Brace, Protex Elbow Brace, The Knight OA
Under Brace Sleeve, Thigh Sleeve, Calf Sleeve, Elbow Sleeve, Tendonitis Strap, Knee Sleeve, Patella Stabilizer
Adjustable Patella Buttress w/Contour Hinge, Adjustable Patella Buttress, Economy Hinged Knee, Sports Cover
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device