MODULAR FOOT SYSTEM
FDA 510(k) clearance K073624 · decided 2008-03-20
Clearance details
- K-number
- K073624
- Device name
- MODULAR FOOT SYSTEM
- Applicant
- Orthohelix Surgical Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-26
- Decision date
- 2008-03-20
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Des recall (Z-1784-2010) | Orthohelix Surgical Designs Inc | 2010-06-10 |