FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
K Number: K201614
·
Decision Jul 15, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
33
Review Days
30
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
- TxTiHA IBF System, AxTiHA Stand-Alone ALIF System
- K Number
- K201614
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- June 15, 2020
- Decision Date
- July 15, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Innovasis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) | Jul 23, 2025 | Substantially Equivalent |
| K250182 | Innovasis Navigation Instruments | Mar 24, 2025 | Substantially Equivalent |
| K241276 | Vector Pedicle Screw System | May 20, 2024 | Substantially Equivalent |
| K231899 | HAtetracell-C Titanium Cervical IBF System | Oct 17, 2023 | Substantially Equivalent |
| K223511 | Excella Navigation Instruments | May 2, 2023 | Substantially Equivalent |
| K223510 | Matrix HA Fusion Porous Cervical IBF System | Dec 12, 2022 | Substantially Equivalent |
| K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Aug 26, 2022 | Substantially Equivalent |
| K212967 | AxTiHA Stand-Alone ALIF System | Oct 15, 2021 | Substantially Equivalent |
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Jun 30, 2020 | Substantially Equivalent |
| K192049 | Oryx Cervical Plate System | Nov 8, 2019 | Substantially Equivalent |