PISCES-SA Standalone ALIF Interbody System
FDA 510(k) K213935 · Osseus Fusion Systems
510(k) numberK213935
Submission
- Device name
- PISCES-SA Standalone ALIF Interbody System
- Applicant
- Osseus Fusion Systems
Dallas, TX, US - Received
- December 16, 2021
- Decision date
- May 6, 2022
- 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 |
|---|---|---|
| K223413 | Pisces-SA STANDALONE ALIF Interbody SystemOVD · Traditional | 02/10/2023SE |
| K222107 | Black Diamond POCT Spinal SystemNKG · Traditional | 11/03/2022SE |
| K213590 | Blue Topaz Sacroiliac Screw SystemOUR · Traditional | 03/01/2022SE |
| K192495 | Black Diamond Navigation InstrumentsOLO · Traditional | 01/17/2020SE |
| K192121 | Black Diamond Pedicle Screw SystemNKB · Traditional | 10/29/2019SE |
| K181347 | Aries® Lumbar InterbodiesMAX · Traditional | 08/15/2018SE |
| K170844 | Gemini-C Hybrid Cervical Interbody SystemODP · Traditional | 07/03/2017SE |
| K160522 | White Pearl Preferred Angle Anterior Cervical PlateKWQ · Traditional | 04/26/2016SE |
| K131810 | Osseus Black Diamond Pedicle Screw SystemMNH · Traditional | 08/08/2013SE |
Questions and answers
When was PISCES-SA Standalone ALIF Interbody System cleared by the FDA?
PISCES-SA Standalone ALIF Interbody System (K213935) received a 510(k) decision of Substantially Equivalent on May 6, 2022, 141 days after the submission was received.
What is the product code of K213935?
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.