Cervical Cage
FDA 510(k) K122444 · Eisertech, LLC
510(k) numberK122444
Submission
- Device name
- Cervical Cage
- Applicant
- Eisertech, LLC
San Diego, CA, US - Received
- August 10, 2012
- Decision date
- August 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K192768 | Temporary Fixation PinsJDW · Traditional | 12/26/2019SE |
| K190565 | Cervical PlateKWQ · Traditional | 05/31/2019SE |
| K140348 | Interbody CageMAX · Traditional | 04/23/2015SE |
| K142576 | Spinal SystemNKB · Traditional | 02/26/2015SE |
| K113170 | Cervical PlateKWQ · Traditional | 04/06/2012SE |
| K113478 | Plif CageMAX · Abbreviated | 03/05/2012SE |
| K110915 | Cervical CageODP · Abbreviated | 07/22/2011SE |
Questions and answers
When was Cervical Cage cleared by the FDA?
Cervical Cage (K122444) received a 510(k) decision of Substantially Equivalent on August 30, 2012, 20 days after the submission was received.
What is the product code of K122444?
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.