Identity
- Trade Name
- Canturio® Smart Extension 14mm (D) x 30mm (H) FDA UDI
- Generic Name
- Knee femur stem prosthesis FDA UDI
- Device Name
- Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software. FDA UDI
- Model / Reference
- 43-5570-030-14 FDA UDI
- Description
- Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003118399 FDA UDI
- 510(k) Number
- K234056 FDA UDI
- FDA Product Code
- QPP FDA UDI
- GMDN Term
- Knee femur stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Knee femur stem prosthesis
Canturio® Smart Extension 14mm (D) x 30mm (H) by Canary Medical Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur stem prosthesis.
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- Biomet Knee System — Biomet Orthopedics, Inc. · Class II
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- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
- Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
- Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Canary Medical Usa Llc
Sources (1)
- FDA UDI 0eca5bb3-7e1c-4058-b18a-1795eca29ee1 34 fields · synced May 30, 2026