K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
FDA 510(k) K212038 · K&J Consulting Corporation
510(k) numberK212038
Submission
- Device name
- K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
- Applicant
- K&J Consulting Corporation
Lansdale, PA, US - Received
- June 30, 2021
- Decision date
- August 27, 2021
- 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 |
|---|---|---|
| K250335 | IVA & AEON Cervical and Lumbar Cage SystemODP · Traditional | 08/29/2025SE |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…MRW · Traditional | 12/13/2023SE |
| K233332 | Statera-C Spinal SystemNKG · Traditional | 11/27/2023SE |
| K232586 | Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal SystemNKB · Traditional | 10/24/2023SE |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…KWQ · Traditional | 07/16/2023SE |
Questions and answers
When was K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage cleared by the FDA?
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K212038) received a 510(k) decision of Substantially Equivalent on August 27, 2021, 58 days after the submission was received.
What is the product code of K212038?
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.