Synthes Zero-P
FDA 510(k) K112459 · Synthes Spine Co.Lp
510(k) numberK112459
Submission
- Device name
- Synthes Zero-P
- Applicant
- Synthes Spine Co.Lp
West Chester, PA, US - Received
- August 26, 2011
- Decision date
- December 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K122211 | Synthes Navigable Pedicle Preparation InstrumentsHAW · Traditional | 12/17/2012SE |
| K120838 | Synthes Matrix SystemNKB · Traditional | 07/31/2012SE |
| K121852 | Synthes Zero-P Variable Angle (Va)OVE · Special | 07/25/2012SE |
| K111048 | Synthes Scout Tack FixationOMR · Traditional | 06/14/2012SESU |
| K120928 | Synthes Matrix SystemNKB · Traditional | 05/18/2012SE |
| K120571 | Synthes Uss ConnectorNKB · Traditional | 05/14/2012SE |
| K113149 | Synthes Uss ConnectorsMNI · Traditional | 02/01/2012SE |
| K113044 | Synthes MirsNKB · Traditional | 12/21/2011SE |
| K111358 | Synthes UssNKB · Traditional | 11/18/2011SE |
| K112068 | Synthes Zero-P Variable Angle (Va)OVE · Traditional | 11/07/2011SE |
Questions and answers
When was Synthes Zero-P cleared by the FDA?
Synthes Zero-P (K112459) received a 510(k) decision of Substantially Equivalent on December 12, 2011, 108 days after the submission was received.
What is the product code of K112459?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.