canturio® se (Canturio Smart Extension)— 510(k) K234056
Substantially EquivalentCanary Medical USA, LLC
FDA 510(k) clearance K234056 for canturio® se (Canturio Smart Extension), Substantially Equivalent on 2024-04-24. Applicant: Canary Medical USA, LLC. Device class: 2.
Clearance details
- Applicant
- Canary Medical USA, LLC
- Product code
- Code QPP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3600
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code QPP
view all- K223803 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K220413 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- DEN200064 — Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System
Recalls naming K234056
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 K234056.
Data sourced from openFDA. This site is unofficial and independent of the FDA.