FDA Registration
Active
🇺🇸 United States
GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
Reg #: 3012478585
·
FEI: 3012478585
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
4
Classifications
7
Registration Details
- Registration Name
- GRAMERCY EXTREMITY ORTHOPEDICS, LLC.
- Registration Number
- 3012478585
- FEI Number
- 3012478585
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1239 N Glenville Dr
- City
- Richardson
- State
- TX
- ZIP
- 75081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210534
Owner / Operator
- Firm Name
- Gramercy Extremity Orthopedics, LLC.
- Operator Number
- 10053967
- Address
- 1239 N. Glenville Drive
- City
- Richardson
- State
- TX
- Postal Code
- 75081
- Country
- US
- Correspondent
- John Rigol
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-01-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-04-19 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-04-19 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-01-26 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2025-01-07 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2025-01-07 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-04-23 |
Proprietary Names
Sagittal Saw Blade
GEO 1st MTP Joint Arthrodesis Plating System
GEO Bone Screw System
GEO Extremity and Ankle Plating System
GEO Hammertoe Screw
Cut Guide, GEO-Desis, Single Slot
GEO-Desis Kit Right
GEO-Desis Kit Left
GEO-Desis Kit Accessories
GEO Staple System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device