510(k) K230088
- Device
- Ankle Truss System (ATS)
- Applicant
- 4Web Medical, Inc.
- 510(k) number
- K230088
- Product code
- SAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-21
- Date received
- 2023-01-12
- Regulation
- 888.3020
- Classification name
- Ankle Fusion Cage
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lewis Harrison
- Address
- 2801 Network Blvd. Suite 620 Frisco TX US 75034 75034
FDA Registration Numbers#
- 3009189869
- 3010370500
- 3014833750
- 3029890418
- 3011127597
Source Documents#
Other 510(k) Records For Product Code SAI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242356 | TIDAL Fusion Cage System | Restor3D, Inc. | 2025-03-24 |