Southern Anterior Screw Fixated Cage (SASCA)
FDA 510(k) K221447 · Southern Medical (Pty) , Ltd.
510(k) numberK221447
Submission
- Device name
- Southern Anterior Screw Fixated Cage (SASCA)
- Applicant
- Southern Medical (Pty) , Ltd.
Irene, ZA - Received
- May 18, 2022
- Decision date
- October 14, 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
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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 |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K253373 | Southern Craniomaxillofacial (CMF) SystemJEY · Traditional | 12/19/2025SE |
| K230608 | SPICCA Stand-Alone Cervical Fusion CagesOVE · Traditional | 08/14/2023SE |
| K230607 | SPICCA Cervical Fusion CagesODP · Traditional | 08/14/2023SE |
| K231145 | Axis Anterior Cervical Plate SystemKWQ · Traditional | 06/13/2023SE |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF)MAX · Traditional | 12/08/2022SE |
Questions and answers
When was Southern Anterior Screw Fixated Cage (SASCA) cleared by the FDA?
Southern Anterior Screw Fixated Cage (SASCA) (K221447) received a 510(k) decision of Substantially Equivalent on October 14, 2022, 149 days after the submission was received.
What is the product code of K221447?
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.