Endoskeleton(R) Tas
FDA 510(k) K111626 · Titan Spine, LLC
510(k) numberK111626
Submission
- Device name
- Endoskeleton(R) Tas
- Applicant
- Titan Spine, LLC
Apple Valley, MN, US - Received
- June 10, 2011
- Decision date
- September 9, 2011
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…OVD · Traditional | 01/08/2020SE |
| K192054 | Endoskeleton TAS PlateOVD · Special | 08/29/2019SE |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…ODP · Special | 08/16/2019SE |
| K191565 | Endoskeleton TCS Interbody Fusion DeviceOVE · Special | 08/06/2019SE |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…ODP · Special | 02/11/2019SE |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…ODP · Special | 02/13/2018SE |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD)MAX · Traditional | 07/06/2017SE |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic…OVD · Traditional | 04/13/2017SE |
| K153122 | Endoskeleton(r) TCS SystemOVE · Traditional | 12/14/2015SE |
| K151596 | Endoskeleton TCS Interbody Fusion DeviceOVE · Traditional | 10/09/2015SE |
Questions and answers
When was Endoskeleton(R) Tas cleared by the FDA?
Endoskeleton(R) Tas (K111626) received a 510(k) decision of Substantially Equivalent on September 9, 2011, 91 days after the submission was received.
What is the product code of K111626?
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.