CONDUIT Cages; FIBERGRAFT BG Putty
FDA 510(k) K222276 · Depuy Spine
510(k) numberK222276
Submission
- Device name
- CONDUIT Cages; FIBERGRAFT BG Putty
- Applicant
- Depuy Spine
Raynham, MA, US - Received
- July 29, 2022
- Decision date
- October 15, 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 |
|---|---|---|
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | 08/31/2020SE |
| K142185 | Expedium Verse Spine SystemNKB · Traditional | 11/19/2014SE |
| K111136 | Expedium Spine System, Viper System, Viper 2 SystemNKB · Traditional | 06/14/2012SESU |
| K121020 | Viper SystemNKB · Special | 05/03/2012SE |
| K110353 | Mountaineer Oct Spinal SystemKWP · Special | 04/07/2011SE |
| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
| K101923 | Concorde Curve SystemMAX · Special | 12/01/2010SE |
| K103100 | Mountaineer Oct Spinal SystemMNI · Special | 11/17/2010SE |
Questions and answers
When was CONDUIT Cages; FIBERGRAFT BG Putty cleared by the FDA?
CONDUIT Cages; FIBERGRAFT BG Putty (K222276) received a 510(k) decision of Substantially Equivalent on October 15, 2022, 78 days after the submission was received.
What is the product code of K222276?
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.