FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nexxt Matrixx System
K Number: K193370
·
Decision Jan 21, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
22
Review Days
47
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Basic Information
- Device Name
- Nexxt Matrixx System
- K Number
- K193370
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexxt Spine, LLC
- Date Received
- December 5, 2019
- Decision Date
- January 21, 2020
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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| K202230 | NEXXT MATRIXX Stand Alone ALIF System | Dec 15, 2020 | Substantially Equivalent |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | Sep 17, 2020 | Substantially Equivalent |
| K200969 | NEXXT MATRIXX System | May 21, 2020 | Substantially Equivalent |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Mar 23, 2020 | Substantially Equivalent |
| K193412 | NEXXT MATRIXX System | Feb 24, 2020 | Substantially Equivalent |
| K192687 | TrellOss-L MPF | Jan 9, 2020 | Substantially Equivalent |
| K191408 | Nexxt Matrixx System | Jul 10, 2019 | Substantially Equivalent |