FDA Registration
Active
🇺🇸 United States
LOCKDOWN SURGICAL. INC.
Reg #: 3010237768
·
FEI: 3010237768
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- LOCKDOWN SURGICAL. INC.
- Registration Number
- 3010237768
- FEI Number
- 3010237768
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6713 Lakeway Dr.
- City
- Chanhassen
- State
- MN
- ZIP
- 55317
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072370
Owner / Operator
- Firm Name
- Lockdown Surgical,Inc.
- Operator Number
- 10046743
- Address
- c/o Signus Medical, 6713 Lakeway Drive
- City
- Chanhassen
- State
- MN
- Postal Code
- 55317
- Country
- US
- Correspondent
- Thomas A Hoghaug
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-02-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2024-02-07 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2024-02-07 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-02-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-02-07 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2024-02-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-02-07 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2024-02-07 |
Proprietary Names
Depth Gauge
LockDown Screwdriver
Surgicraft Surgical Mesh
LockDown Washer
Drill
Passer
LockDown Acromialclavicular (AC) Device
LockDown Length Gauge
Establishment Types
Complaint File Establishment per 21 CFR 820.198