FDA Registration
Active
🇺🇸 United States
LEM SURGICAL INC
Reg #: 3039520898
·
FEI: 3039520898
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LEM SURGICAL INC
- Registration Number
- 3039520898
- FEI Number
- 3039520898
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4830 W Kennedy Blvd Ste 130
- City
- Tampa
- State
- FL
- ZIP
- 33609
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243326
Owner / Operator
- Firm Name
- LEM Surgical Inc
- Operator Number
- 10093854
- Address
- 4830 W Kennedy Blvd, Suite 130
- City
- Tampa
- State
- FL
- Postal Code
- 33609
- Country
- US
- Correspondent
- Christopher S Prentice
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-07-23 |
Proprietary Names
Dynamis Robotic Surgical System
Establishment Types
Complaint File Establishment per 21 CFR 820.198