HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC Biologics Osteopoint Lumbar PEEK Cages
FDA 510(k) K260340 · HC Biologics, LLC
510(k) numberK260340
Submission
- Device name
- HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC Biologics Osteopoint Lumbar PEEK Cages
- Applicant
- HC Biologics, LLC
Miami, FL, US - Received
- February 2, 2026
- Decision date
- April 13, 2026
- 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 |
| K242303 | Mod-CODP · Traditional | Orthomod, LLC | 04/01/2026SE |
More from Orthomod, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250092 | HC Biologics Osteopoint Spinal Fixation SystemNKB · Traditional | 03/27/2025SE |
Questions and answers
When was HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC Biologics Osteopoint Lumbar PEEK Cages cleared by the FDA?
HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC Biologics Osteopoint Lumbar PEEK Cages (K260340) received a 510(k) decision of Substantially Equivalent on April 13, 2026, 70 days after the submission was received.
What is the product code of K260340?
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.