Life Spine Stand-Alone Spacer System
FDA 510(k) K091301 · Life Spine
510(k) numberK091301
Submission
- Device name
- Life Spine Stand-Alone Spacer System
- Applicant
- Life Spine
Hoffman Estates, IL, US - Received
- May 4, 2009
- Decision date
- December 15, 2009
- 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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| K261430 | TruLift Expandable SystemMAX · Traditional | 07/28/2026SE |
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| K254274 | ARx® SAI Implant SystemNKB · Traditional | 04/16/2026SE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemMAX · Traditional | 01/23/2026SE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemMAX · Traditional | 07/07/2025SE |
| K250373 | ProLift Expandable Spacer SystemMAX · Traditional | 04/09/2025SE |
| K243668 | ProLift Pivot Expandable Spacer SystemMAX · Traditional | 01/23/2025SE |
| K243369 | Cervical Plating SystemKWQ · Traditional | 12/11/2024SE |
| K242826 | ProLift Wedge Expandable Spacer SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was Life Spine Stand-Alone Spacer System cleared by the FDA?
Life Spine Stand-Alone Spacer System (K091301) received a 510(k) decision of Substantially Equivalent on December 15, 2009, 225 days after the submission was received.
What is the product code of K091301?
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.