FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
K Number: K240872
·
Decision Apr 26, 2024
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
10
Review Days
28
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
- Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
- K Number
- K240872
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clariance
- Date Received
- March 29, 2024
- Decision Date
- April 26, 2024
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
Socko Vimax Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ChanPin Pedicle Screw Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Varion Thoracolumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
FDA 510(k)
FDA Class 2
·Orthopedic
AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
PERLA® TL Posterior Thoraco-lumbar Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Clariance
| K Number | Device Name | ||
|---|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | Jan 14, 2025 | Substantially Equivalent |
| K243670 | Idys® LIF | Dec 31, 2024 | Substantially Equivalent |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Jul 24, 2024 | Substantially Equivalent |
| K240715 | Idys® C ZP 3DTi | Mar 22, 2024 | Substantially Equivalent |
| K220182 | Aggeris-C | Mar 30, 2022 | Substantially Equivalent |
| K200919 | Idys ALIF 3DTi | Apr 12, 2021 | Substantially Equivalent |
| K130853 | IDYS(TM) C | Nov 13, 2013 | Substantially Equivalent |
| K131178 | IDYS LIF CAGES | Oct 10, 2013 | Substantially Equivalent |
| K120469 | ERISMA-LP | Aug 13, 2012 | Substantially Equivalent |