ChoiceSpine Stealth Cervical Spacer System
FDA 510(k) K183397 · Choicespine, LP
510(k) numberK183397
Submission
- Device name
- ChoiceSpine Stealth Cervical Spacer System
- Applicant
- Choicespine, LP
Knoxville, TN, US - Received
- December 7, 2018
- Decision date
- March 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K190227 | Boomerang Anterior Cervical Plate SystemKWQ · Traditional | 05/01/2019SE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Special | 02/22/2019SE |
| K182721 | Choice Spine Navigation SystemOLO · Traditional | 01/08/2019SE |
| K183214 | Raven Lumbar Plate SystemKWQ · Traditional | 01/03/2019SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | 05/16/2018SE |
| K172816 | TiGer Shark SystemMAX · Traditional | 01/26/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | 01/19/2018SE |
| K171489 | Acapella Cervical Spacer SystemOVE · Traditional | 10/23/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | 09/15/2017SE |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw SystemsNKB · Traditional | 08/03/2017SE |
Questions and answers
When was ChoiceSpine Stealth Cervical Spacer System cleared by the FDA?
ChoiceSpine Stealth Cervical Spacer System (K183397) received a 510(k) decision of Substantially Equivalent on March 6, 2019, 89 days after the submission was received.
What is the product code of K183397?
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.