FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K Number: K023797
·
Decision Dec 13, 2002
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
154
Review Days
29
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
- LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
- K Number
- K023797
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Sofamor Danek
- Date Received
- November 14, 2002
- Decision Date
- December 13, 2002
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWP), ordered by most recent decision date.
LnK Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
Sure Lok Mini Posterior Cervical/Upper Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Reliance Posterior Cervical-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Streamline OCT Occipito-Cervico-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
SOLSTICE OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medtronic Sofamor Danek
| K Number | Device Name | ||
|---|---|---|---|
| K212428 | Centerpiece Plate Fixation System | Dec 13, 2021 | Substantially Equivalent |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Aug 26, 2020 | Substantially Equivalent |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | Dec 20, 2017 | Substantially Equivalent |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | Sep 19, 2017 | Substantially Equivalent |
| K171031 | CRESCENT Spinal System | Jul 6, 2017 | Substantially Equivalent |
| K171468 | FUSE Spinal System | Jun 13, 2017 | Substantially Equivalent |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | May 11, 2017 | Substantially Equivalent |
| K161210 | RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems | Aug 12, 2016 | Substantially Equivalent |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device | Jan 19, 2016 | Substantially Equivalent |
| K140276 | CD HORIZON SPINAL SYSTEM | Mar 13, 2014 | Substantially Equivalent |