Scarlet Ac-T
FDA 510(k) K172065 · Spineart
510(k) numberK172065
Submission
- Device name
- Scarlet Ac-T
- Applicant
- Spineart
Plan Les Ouates, CH - Received
- July 7, 2017
- Decision date
- September 29, 2017
- 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 |
|---|---|---|
| K261049 | Scala® TLMAX · Traditional | 08/20/2026SE |
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | 08/14/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | 07/29/2026SE |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation SystemNKB · Traditional | 05/01/2026SE |
| K254158 | SPINEART Navigation Instrument SystemOLO · Special | 04/09/2026SE |
| K242933 | SPINEART Navigation Instrument SystemOLO · Traditional | 06/18/2025SE |
| K242890 | SPINEART Navigation Instrument SystemOLO · Traditional | 03/07/2025SE |
| K242589 | Scarlet® AL-TMAX · Traditional | 10/23/2024SE |
| K241644 | SPINEART Navigation Instrument SystemOLO · Special | 08/07/2024SE |
| K241321 | Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional | 07/18/2024SE |
Questions and answers
When was Scarlet Ac-T cleared by the FDA?
Scarlet Ac-T (K172065) received a 510(k) decision of Substantially Equivalent on September 29, 2017, 84 days after the submission was received.
What is the product code of K172065?
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.