FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Panta 2 Arthrodesis Nail System
K Number: K181639
·
Decision Nov 2, 2018
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
65
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Panta 2 Arthrodesis Nail System
- K Number
- K181639
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- June 21, 2018
- Decision Date
- November 2, 2018
- Product Code
- HSB
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Integra LifeSciences Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Oct 8, 2025 | Substantially Equivalent |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Apr 9, 2025 | Substantially Equivalent |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2024 | Substantially Equivalent |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2023 | Substantially Equivalent |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Aug 22, 2022 | Substantially Equivalent |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 15, 2022 | Substantially Equivalent |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Oct 8, 2021 | Substantially Equivalent |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | Jul 27, 2021 | Substantially Equivalent |
| K193346 | Codman Surgical Patties & Strips | Nov 20, 2020 | Substantially Equivalent |
| K201507 | Cadence Total Ankle System | Jun 29, 2020 | Substantially Equivalent |