WaveForm A Interbody System
FDA 510(k) K222732 · SeaSpine Orthopedics Corporation
510(k) numberK222732
Submission
- Device name
- WaveForm A Interbody System
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- September 9, 2022
- Decision date
- November 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | 07/01/2026SE |
| K250908 | Virata Spinal Fixation SystemNKB · Traditional | 06/18/2025SE |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLO · Traditional | 04/02/2025SE |
| K242273 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/25/2024SE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…MAX · Special | 06/20/2024SE |
| K240566 | Reef L Interbody System; WaveForm L Interbody SystemMAX · Traditional | 04/26/2024SE |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…NKB · Traditional | 04/19/2024SE |
| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | 01/12/2024SE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody SystemOVE · Traditional | 11/28/2023SE |
| K232668 | Cove Strip, OsteoCove StripMQV · Special | 09/27/2023SE |
Questions and answers
When was WaveForm A Interbody System cleared by the FDA?
WaveForm A Interbody System (K222732) received a 510(k) decision of Substantially Equivalent on November 7, 2022, 59 days after the submission was received.
What is the product code of K222732?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.