Manta Ray TDF Spacer
FDA 510(k) K220296 · SeaSpine Orthopedics Corporation
510(k) numberK220296
Submission
- Device name
- Manta Ray TDF Spacer
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- February 2, 2022
- Decision date
- February 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 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 Manta Ray TDF Spacer cleared by the FDA?
Manta Ray TDF Spacer (K220296) received a 510(k) decision of Substantially Equivalent on February 3, 2023, 366 days after the submission was received.
What is the product code of K220296?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.