Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
FDA 510(k) K150643 · Centinel Spine, Inc.
510(k) numberK150643
Submission
- Device name
- Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
- Applicant
- Centinel Spine, Inc.
West Chester, PA, US - Received
- March 12, 2015
- Decision date
- June 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar 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 OVD
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|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
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| 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 |
| K141942 | Midline II TiOVD · Traditional | 11/07/2014SE |
| K142079 | Stalif Cti, Stalif COVE · Traditional | 10/24/2014SE |
| K133200 | Stalif C(R)OVE · Traditional | 05/08/2014SE |
| K133286 | Midline (TM)OVD · Special | 01/09/2014SE |
Questions and answers
When was Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti cleared by the FDA?
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (K150643) received a 510(k) decision of Substantially Equivalent on June 8, 2015, 88 days after the submission was received.
What is the product code of K150643?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.