FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAtetracell-C Titanium Cervical IBF System
K Number: K231899
·
Decision Oct 17, 2023
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
33
Review Days
111
Basic Information
- Device Name
- HAtetracell-C Titanium Cervical IBF System
- K Number
- K231899
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovasis, Inc.
- Date Received
- June 28, 2023
- Decision Date
- October 17, 2023
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
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 |
| 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 |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Jul 15, 2020 | 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 |