FDA Registration
Active
🇺🇸 United States
20.50 Patellofemoral
Reg #: 2028253
·
FEI: 1000125378
·
Expires 2025
Products
1
Proprietary Names
49
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BREG, INC.,
- Registration Number
- 2028253
- FEI Number
- 1000125378
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2382 Faraday Avenue, Suite 300
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Owner / Operator
- Firm Name
- Breg Inc
- Operator Number
- 10041297
- Address
- 2382 Faraday Avenue, Suite 300
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Monique Zamora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2012-07-27 |
Proprietary Names
20.50 Patellofemoral
Original Knee
Axiom
Z-12
DUO
Wee-Rom
OR Merit
G3
Z-13
Revolution 3
Jet
Thruster RLF
Extender Plus
Quantum OA
Latitude OA Knee
LPR
Post-Op
T-Scope Premier
Undersleeve
Patella Guard
Hi-Performance
Genesis
ShortRunner
OA Impulse
Solus Knee Brace
Freestyle
PTO
Economy Hinged Knee
Crossover
Recover
Hinge Cover
Lateral Stabilizer
Slide Guard
RoadRunner
FreeSport
EPO
FreeRunner
X2K Knee Brace
Hinged Knee
Fusion Knee
Accessories - Incision Pad, Pad, Pad Kit, Refurb Kit, Cuff, Wrap Set, Hinge Kit, Shims Kit
CrossRunner
TopShelf Fusion Strap Set
MC Knee Brace
Accessories - Condyle and Hook, Patella Buttress, Strap set, Strap Tab, Strap Pad, Calf Strap, Condyle, Hex Key
Measuring System, Fit Kit
Accessories - Stop Kit, Soft Toe Guard, Soft Goods, Shoe Insert, Buckle, Chafe Tab, Shoe insert, Hard toe guard
Performance Knit Hinged
Knee Support
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility