FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smart Correction System
K Number: K193368
·
Decision Sep 18, 2020
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
8
Review Days
288
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Basic Information
- Device Name
- Smart Correction System
- K Number
- K193368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wishbone Medical, Inc.
- Date Received
- December 5, 2019
- Decision Date
- September 18, 2020
- Product Code
- KTT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Wishbone Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231461 | Smart Correction System (HA Half Pins) | Jun 16, 2023 | Substantially Equivalent |
| K230527 | WishBone Medical Plate and Screw System | Mar 29, 2023 | Substantially Equivalent |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Jun 6, 2022 | Substantially Equivalent |
| K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate | Jan 27, 2022 | Substantially Equivalent |
| K203467 | WishBone Medical Plate and Screw System | Dec 23, 2020 | Substantially Equivalent |
| K180736 | WishBone Medical Plate and Screw System | Oct 4, 2018 | Substantially Equivalent |
| K173013 | WishBone K-Wire System | Dec 14, 2017 | Substantially Equivalent |