Panta 2 Arthrodesis Nail System
FDA 510(k) K181639 · Integra LifeSciences Corporation
510(k) numberK181639
Submission
- Device name
- Panta 2 Arthrodesis Nail System
- Applicant
- Integra LifeSciences Corporation
Austin, TX, US - Received
- June 21, 2018
- Decision date
- November 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Panta 2 Arthrodesis Nail System cleared by the FDA?
Panta 2 Arthrodesis Nail System (K181639) received a 510(k) decision of Substantially Equivalent on November 2, 2018, 134 days after the submission was received.
What is the product code of K181639?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.