HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
FDA 510(k) K220875 · Innovasis, Inc.
510(k) numberK220875
Submission
- Device name
- HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
- Applicant
- Innovasis, Inc.
Salt Lake City, UT, US - Received
- March 25, 2022
- Decision date
- August 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250076 | Endeavor Stand-Alone Cervical IBF SystemOVE · Traditional | 09/25/2025SE |
| K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional | 07/23/2025SE |
| K250603 | AxTiHA® Stand-Alone ALIF SystemOVD · Special | 03/24/2025SE |
| K250182 | Innovasis Navigation InstrumentsOLO · Traditional | 03/24/2025SE |
| K241276 | Vector Pedicle Screw SystemNKB · Traditional | 05/20/2024SE |
| K231899 | HAtetracell-C Titanium Cervical IBF SystemODP · Traditional | 10/17/2023SE |
| K223511 | Excella Navigation InstrumentsOLO · Traditional | 05/02/2023SE |
| K223510 | Matrix HA Fusion Porous Cervical IBF SystemODP · Special | 12/12/2022SE |
| K212967 | AxTiHA Stand-Alone ALIF SystemOVD · Special | 10/15/2021SE |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemMAX · Special | 07/15/2020SE |
Questions and answers
When was HAcancellous PEEK-C Porous HA PEEK Cervical IBF System cleared by the FDA?
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (K220875) received a 510(k) decision of Substantially Equivalent on August 26, 2022, 154 days after the submission was received.
What is the product code of K220875?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.