FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXXT MATRIXX System
K Number: K193412
·
Decision Feb 24, 2020
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
17
Applicant Total
22
Review Days
77
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Basic Information
- Device Name
- NEXXT MATRIXX System
- K Number
- K193412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexxt Spine, LLC
- Date Received
- December 9, 2019
- Decision Date
- February 24, 2020
- Product Code
- PLR
- 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 |
|---|---|---|---|
| PLR | Spinal Vertebral Body Replacement Device - Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Nexxt Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw System | Jul 20, 2023 | Substantially Equivalent |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw System | Jul 28, 2022 | Substantially Equivalent |
| K220291 | NEXXT SPINE NAVIGATION System | Mar 31, 2022 | Substantially Equivalent |
| 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 |
| K193370 | Nexxt Matrixx System | Jan 21, 2020 | Substantially Equivalent |
| K192687 | TrellOss-L MPF | Jan 9, 2020 | Substantially Equivalent |
| K191408 | Nexxt Matrixx System | Jul 10, 2019 | Substantially Equivalent |