CalcaNail Orthopedic Nail
FDA 510(k) K150463 · Fournitures Hospitalieres Industrie
510(k) numberK150463
Submission
- Device name
- CalcaNail Orthopedic Nail
- Applicant
- Fournitures Hospitalieres Industrie
Quimper, FR - Received
- February 23, 2015
- Decision date
- May 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K170040 | BePOD Cannulated Arthrodesis ScrewsHWC · Traditional | 04/04/2017SE |
| K150568 | ARROW Humeral stems size 6 and 16PHX · Traditional | 10/29/2015SE |
| K150471 | CalcaNail Orthopedic Arthrodesis NailHSB · Traditional | 05/22/2015SE |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid basePHX · Traditional | 03/20/2015SE |
| K120740 | Cols® Fixation SystemMBI · Special | 03/05/2013SE |
| K112193 | Arrow Reverse Shoulder SystemPHX · Traditional | 07/12/2012SE |
Questions and answers
When was CalcaNail Orthopedic Nail cleared by the FDA?
CalcaNail Orthopedic Nail (K150463) received a 510(k) decision of Substantially Equivalent on May 22, 2015, 88 days after the submission was received.
What is the product code of K150463?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.