Idys(Tm) C
FDA 510(k) K130853 · Clariance
510(k) numberK130853
Submission
- Device name
- Idys(Tm) C
- Applicant
- Clariance
Philedelphia, PA, US - Received
- March 28, 2013
- Decision date
- November 13, 2013
- 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 |
|---|---|---|
| K243904 | Elegance® Anterior Cervical plateKWQ · Special | 01/14/2025SE |
| K243670 | Idys® LIFMAX · Special | 12/31/2024SE |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special | 07/24/2024SE |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special | 04/26/2024SE |
| K240715 | Idys® C ZP 3DTiOVE · Special | 03/22/2024SE |
| K220182 | Aggeris-CKWQ · Traditional | 03/30/2022SE |
| K212562 | Idys-C ZP 3DTiOVE · Traditional | 10/12/2021SE |
| K200919 | Idys ALIF 3DTiMAX · Traditional | 04/12/2021SE |
| K202032 | Idys LLIF 3DTiOVD · Traditional | 04/01/2021SE |
| K202956 | Erisma LP Navigated InstrumentsOLO · Traditional | 02/26/2021SE |
Questions and answers
When was Idys(Tm) C cleared by the FDA?
Idys(Tm) C (K130853) received a 510(k) decision of Substantially Equivalent on November 13, 2013, 230 days after the submission was received.
What is the product code of K130853?
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.