Smart Correction System
FDA 510(k) clearance K193368 · decided 2020-09-18
Clearance details
- K-number
- K193368
- Device name
- Smart Correction System
- Applicant
- Wishbone Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-05
- Decision date
- 2020-09-18
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation de recall (Z-1102-2023) | Wishbone Medical, Inc. | 2023-02-07 |