Stalif C(R)
FDA 510(k) K133200 · Centinel Spine, Inc.
510(k) numberK133200
Submission
- Device name
- Stalif C(R)
- Applicant
- Centinel Spine, Inc.
West Chester, PA, US - Received
- October 17, 2013
- Decision date
- May 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K250554 | prodisc® L InstrumentsQLQ · Traditional | 04/25/2025SE |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | 12/17/2024SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | 08/19/2022SE |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…MAX · Traditional | 05/08/2018SE |
| K152211 | PCT SystemNKG · Traditional | 12/01/2015SE |
| K150053 | STALIF C; STALIF C-TiOVE · Traditional | 06/24/2015SE |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD · Traditional | 06/08/2015SE |
| K141942 | Midline II TiOVD · Traditional | 11/07/2014SE |
| K142079 | Stalif Cti, Stalif COVE · Traditional | 10/24/2014SE |
| K133286 | Midline (TM)OVD · Special | 01/09/2014SE |
Questions and answers
When was Stalif C(R) cleared by the FDA?
Stalif C(R) (K133200) received a 510(k) decision of Substantially Equivalent on May 8, 2014, 203 days after the submission was received.
What is the product code of K133200?
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.