Catalyft LS Expandable Interbody System
FDA 510(k) K241992 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK241992
Submission
- Device name
- Catalyft LS Expandable Interbody System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- July 8, 2024
- Decision date
- October 28, 2024
- 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 |
|---|---|---|
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | 07/14/2026SE |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemGEI · Traditional | 06/05/2026SE |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemNKB · Traditional | 04/21/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | 01/21/2026SE |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)NKB · Special | 01/07/2026SE |
| K253335 | CD Horizon Spinal SystemNKB · Special | 10/24/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | 10/24/2025SE |
| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | 09/04/2025SE |
| K251395 | The Rialto SI Fusion SystemOUR · Traditional | 06/26/2025SE |
Questions and answers
When was Catalyft LS Expandable Interbody System cleared by the FDA?
Catalyft LS Expandable Interbody System (K241992) received a 510(k) decision of Substantially Equivalent on October 28, 2024, 112 days after the submission was received.
What is the product code of K241992?
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.