Smart Correction System— 510(k) K193368
Substantially EquivalentWishbone Medical, Inc.
FDA 510(k) clearance K193368 for Smart Correction System, Substantially Equivalent on 2020-09-18. Applicant: Wishbone Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wishbone Medical, Inc.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KTT
view allMore clearances from Wishbone Medical, Inc.
view all- K231461 — Smart Correction System (HA Half Pins)
- K230527 — WishBone Medical Plate and Screw System
- K221366 — Smart Correction System Rings and Compatible HA-Coated Half Pins
- K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
- K203467 — WishBone Medical Plate and Screw System
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193368
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193368.
Data sourced from openFDA. This site is unofficial and independent of the FDA.